AzTrials
AzTrials

EbolaPhase 2NCT02818582

GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

A Phase 2 study testing GS-5734 in people with Ebola, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. Read more about this study

Who is it for?
Ages 18 to 99 years, men only
Conditions the study is for
Ebola
What is being tested?
GS-5734
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
2 sitesin 2 countries
Study dates
1 Jul 2016to 31 Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals must meet all of the following criteria to be eligible for study participation:
  • Men more than or equal to 18 years of age.
  • One of two semen samples with Ebola virus RNA detection (defined as a positive PCR for NP or GP using the GeneXpert assay within 42 days prior to randomization).
  • Willingness to be available for study evaluations for 6 months.
  • Willingness to allow storage of biological samples.
  • Willingness to be followed by a Participant Tracker.
  • Willingness to refrain from alcohol consumption for study days -7 to 14.
  • Willingness to comply with MOH \& CDC guidance on using a condom for sexual activity and at least through week 24 of the study.

Who cannot join

  • Individuals meeting any of the following criteria will be excluded from study participation:
  • Estimated glomerular filtration rate less than 60 mL/min/1.73m^2
  • History of significant renal disease
  • History of significant liver disease
  • Evidence of liver disease on physical exam such as ascites
  • Aspartate transaminase (AST) or alanine transaminase (ALT), greater than the upper limit of normal, a prothrombin time 1.1 times greater than the upper limits of normal, normal, or a total bilirubin > 1.5 times the upper limits of normal(per Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity tables version 2.0 Nov. 2014).
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  • Presence of Grade 2 or higher abnormalities for: low hemoglobin, low white blood count (WBC), low platelets, or low or high potassium (per DAIDS toxicity tables version 2.0 Nov. 2014).
  • Presence of greater than Grade 2 abnormalities for low or high sodium (per DAIDS toxicity tables version 2.0 Nov. 2014).
  • Any condition that, in the opinion of the investigator, would compromise the safety of the study subject or staff, or would prevent proper conduct of the study.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Guinea1 site

  • Partnership of Clinical Research in Guinea (PREGUI) / Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah

    Forécariah, Maferinyah

Other trials in Guinea

Liberia1 site

  • JFK Hospital Partnership for Research for Vaccines and Infectious Diseases in Liberia (PREVAIL)

    Monrovia, FWA00021658

Other trials in Liberia

About this study

Official title: PREVAIL IV: Double-Blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Background:

Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, might help get rid of Ebola virus in semen.

Read more

Objective:

To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans.

Eligibility:

Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola virus in their semen

Design:

Participants will be screened with:

Questions

Physical exam

Eye exam

Blood tests

2 semen samples if they have not had it tested recently

Participants must live near the study site in Liberia for 6 months.

Participants will be put into 1 of 2 study groups. They will have an infusion of either GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The infusion lasts 1 hour.

Participants will be observed for 1 hour after. They will provide a semen sample on infusion day 4.

After the infusions, participants will have 5 visits in the first month, then 1 per month for 5 more months. These include giving a blood and semen sample.

Blood tests are performed before and after each infusion and the last visit (5 month visit) will also include an eye exam.

When the study is over, if the study drug works and is safe, participants who got the placebo can get the study drug.

Read the detailed description

With the unprecedented size of the recent 2014-2016 West African Ebola outbreak, the scientific community is learning a great deal about the psychological and physical consequences of Ebola, Ebola viral persistence in survivors, risk of Ebola disease relapse in survivors, and the potential for survivors to transmit the virus to others. Data from PREVAIL III has demonstrated that persistence of Ebola virus in the semen of male survivors is common. In addition to Ebola virus persistence, Ebola relapse causing clinical disease has been well documented.

There are no licensed therapies for the treatment of Ebola virus disease nor for the clearance of persistent Ebola virus in survivors. A safe, effective therapy that can reduce and/or eliminate persistent Ebola virus from semen would reduce the risk of transmission and enable male survivors to resume normal sexual relations without fear of harming loved ones. The mechanism underlying Post-Ebola Syndrome is as yet unknown, but improvement in Post-Ebola signs and symptoms resulting from GS-5734 treatment would be an added benefit.

This study is a double-blind, randomized, two-phase (treatment and longer-term follow-up), two- arm trial of GS-5734 versus placebo among male Ebola survivors with persistent Ebola virus RNA in their semen. Participants are randomized 1:1 to receive either 100 mg of GS-5734 or placebo once daily by intravenous catheter for 5 days. Informed by transaminase elevations in prior Phase I studies in normal healthy subjects, a risk-mitigation strategy includes a built-in dose de-escalation. Participants will be stratified by country and on the basis of one versus two positive semen samples for Ebola virus RNA using the Cepheid GeneXpert platform assessed within 42 days prior to study enrollment. The early Data Safety and Monitoring Board (DSMB) review in August 2016 concluded there was no need for a cohort dose reduction. The protocol expanded to Guinea in October 2017, where the outbreak ended later. Currently there is an outbreak in the Democratic Republic of the Congo where the study team may evaluate conducting this study following the completion of the outbreak.

Antiviral activity, as well as safety and tolerability, will be assessed during the treatment phase. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase. Primary analyses for the assessment of antiviral activity in the treatment phase will focus on the assay negativity rate (ANR; percentage of genital samples that are negative for Ebola) over the first 28 days of the study, as well as clinical and laboratory adverse events. A sample is considered negative by PCR if the test result is undetectable. Primary analysis for the follow-up phase will focus on the ANR collected monthly from months 2 to 6.

Conditions
Ebola
Being tested
GS-5734, Placebo Comparator
Keywords
Liberia, Guinea
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GS-5734Drug

    Daily GS-5734 delivered intravenously (IV) for 5 days

  • Placebo ComparatorOther

    Placebo delivered intravenously (IV) for 5 days.

Study groups in NCT02818582
Study groupRoleWhat they receive
GS-5734 100mg given intravenously daily for 5 daysActive comparatorMale Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days
Receives: Drug: GS-5734
Normal saline intravenously for 5 daysPlacebo comparatorMale Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days
Receives: Other: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

    Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

    Measured: Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)

  2. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

    Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

    Measured: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)

Secondary outcomes (257)

  1. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase

    Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

    Measured: Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)

  2. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase

    Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

    Measured: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)

  3. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at day 1

    Measured: Treatment phase - Day 1

  4. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at day 2

    Measured: Treatment phase - Day 2

  5. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at day 3

    Measured: Treatment phase - Day 3

  6. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at day 4

    Measured: Treatment phase - Day 4

  7. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at day 5

    Measured: Treatment phase - Day 5

  8. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at day 8

    Measured: Treatment phase - Day 8

  9. Mean Change From Baseline in ALT Value at Day 11

    Mean change from baseline in alanine transaminase (ALT) value at day 11

    Measured: Treatment phase - Day 11

  10. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at day 16

    Measured: Treatment phase - Day 16

  11. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at at day 24

    Measured: Treatment phase - Day 24

  12. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at at day 28

    Measured: Treatment phase - Day 28

  13. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at week 8

    Measured: Follow-up phase - Week 8

  14. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) Value at week 12

    Measured: Follow-up phase - Week 12

  15. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at week 16

    Measured: Follow-up phase - Week 16

  16. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at week 20

    Measured: Follow-up phase - Week 20

  17. Mean Change From Baseline in ALT Value

    Mean change from baseline in alanine transaminase (ALT) value at week 24

    Measured: Follow-up phase - Week 24

  18. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1

    Measured: Treatment phase - Day 1

  19. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2

    Measured: Treatment phase - Day 2

  20. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3

    Measured: Treatment phase - Day 3

  21. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4

    Measured: Treatment phase - Day 4

  22. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5

    Measured: Treatment phase - Day 5

  23. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8

    Measured: Treatment phase - Day 8

  24. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11

    Measured: Treatment phase - Day 11

  25. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16

    Measured: Treatment phase - Day 16

  26. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24

    Measured: Treatment phase - Day 24

  27. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28

    Measured: Treatment phase - Day 28

  28. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8

    Measured: Follow-up phase - Week 8

  29. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12

    Measured: Follow-up phase - Week 12

  30. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16

    Measured: Follow-up phase - Week 16

  31. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20

    Measured: Follow-up phase - Week 20

  32. Mean Change From Baseline in aPTT Value

    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24

    Measured: Follow-up phase - Week 24

  33. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) Value at day 1

    Measured: Treatment phase - Day 1

  34. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) Value at day 2

    Measured: Treatment phase - Day 2

  35. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 3

    Measured: Treatment phase - Day 3

  36. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 4

    Measured: Treatment phase - Day 4

  37. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 5

    Measured: Treatment phase - Day 5

  38. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 8

    Measured: Treatment phase - Day 8

  39. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 11

    Measured: Treatment phase - Day 11

  40. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 16

    Measured: Treatment phase - Day 16

  41. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 24

    Measured: Treatment phase - Day 24

  42. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at day 28

    Measured: Treatment phase - Day 28

  43. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at week 8

    Measured: Follow-up phase - Week 8

  44. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12

    Measured: Follow-up phase - Week 12

  45. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16

    Measured: Follow-up phase - Week 16

  46. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20

    Measured: Follow-up phase - Week 20

  47. Mean Change From Baseline in AST Value

    Mean change from baseline in aspartate transaminase (AST) value at week 24

    Measured: Follow-up phase - Week 24

  48. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 1

    Measured: Treatment phase - Day 1

  49. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 2

    Measured: Treatment phase - Day 2

  50. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 3

    Measured: Treatment phase - Day 3

  51. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 4

    Measured: Treatment phase - Day 4

  52. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 5

    Measured: Treatment phase - Day 5

  53. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 8

    Measured: Treatment phase - Day 8

  54. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 11

    Measured: Treatment phase - Day 11

  55. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 16

    Measured: Treatment phase - Day 16

  56. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 24

    Measured: Treatment phase - Day 24

  57. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at day 28

    Measured: Treatment phase - Day 28

  58. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at week 8

    Measured: Follow-up phase - Week 8

  59. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at week 12

    Measured: Follow-up phase - Week 12

  60. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at week 16

    Measured: Follow-up phase - Week 16

  61. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at week 20

    Measured: Follow-up phase - Week 20

  62. Mean Change From Baseline in INR Value

    Mean change from baseline in international normalized ratio (INR) value at week 24

    Measured: Follow-up phase - Week 24

  63. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 1

    Measured: Treatment phase - Day 1

  64. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 2

    Measured: Treatment phase - Day 2

  65. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 3

    Measured: Treatment phase - Day 3

  66. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 4

    Measured: Treatment phase - Day 4

  67. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 5

    Measured: Treatment phase - Day 5

  68. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 8

    Measured: Treatment phase - Day 8

  69. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 11

    Measured: Treatment phase - Day 11

  70. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 16

    Measured: Treatment phase - Day 16

  71. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 24

    Measured: Treatment phase - Day 24

  72. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at day 28

    Measured: Treatment phase - Day 28

  73. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at week 8

    Measured: Follow-up phase - Week 8

  74. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at week 12

    Measured: Follow-up phase - Week 12

  75. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at week 16

    Measured: Follow-up phase - Week 16

  76. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at week 20

    Measured: Follow-up phase - Week 20

  77. Mean Change From Baseline in PT Value

    Mean change from baseline in prothrombin time (PT) value at week 24

    Measured: Follow-up phase - Week 24

  78. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) [DAIDS AE grading table] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 1

  79. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 2

  80. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 3

  81. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 4

  82. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 5

  83. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 8

  84. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 11

  85. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 16

  86. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 24

  87. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 28

  88. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 8

  89. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 12

  90. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 16

  91. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 20

  92. Number of Participants With Increase in Grade From Baseline for ALT Value

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 24

  93. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 1

  94. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 2

  95. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 3

  96. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 4

  97. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 5

  98. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 8

  99. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 11

  100. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 16

  101. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 24

  102. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 28

  103. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 8

  104. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 12

  105. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 16

  106. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 20

  107. Number of Participants With Increase in Grade From Baseline for aPTT Value

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 24

  108. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 1

  109. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 2

  110. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 3

  111. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 4

  112. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 5

  113. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 8

  114. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 11

  115. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 16

  116. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 24

  117. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Treatment phase - Day 28

  118. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 8

  119. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 12

  120. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 16

  121. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 20

  122. Number of Participants With Increase in Grade From Baseline for AST Value

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (> 10 x ULN)

    Measured: Follow-up phase - Week 24

  123. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 1

  124. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 2

  125. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 3

  126. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 4

  127. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 5

  128. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 8

  129. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 11

  130. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 16

  131. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 24

  132. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Treatment phase - Day 28

  133. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 8

  134. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 12

  135. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 16

  136. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 20

  137. Number of Participants With Increase in Grade From Baseline for PT Value

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (> 3.00 x ULN)

    Measured: Follow-up phase - Week 24

  138. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1

    Measured: Treatment phase - Day 1

  139. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2

    Measured: Treatment phase - Day 2

  140. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3

    Measured: Treatment phase - Day 3

  141. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4

    Measured: Treatment phase - Day 4

  142. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5

    Measured: Treatment phase - Day 5

  143. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8

    Measured: Treatment phase - Day 8

  144. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11

    Measured: Treatment phase - Day 11

  145. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16

    Measured: Treatment phase - Day 16

  146. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24

    Measured: Treatment phase - Day 24

  147. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28

    Measured: Treatment phase - Day 28

  148. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8

    Measured: Follow-up phase - Week 8

  149. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12

    Measured: Follow-up phase - Week 12

  150. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16

    Measured: Follow-up phase - Week 16

  151. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20

    Measured: Follow-up phase - Week 20

  152. Participants With Grade 1 ALT Level

    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24

    Measured: Follow-up phase - Week 24

  153. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1

    Measured: Treatment phase - Day 1

  154. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2

    Measured: Treatment phase - Day 2

  155. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3

    Measured: Treatment phase - Day 3

  156. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4

    Measured: Treatment phase - Day 4

  157. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5

    Measured: Treatment phase - Day 5

  158. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8

    Measured: Treatment phase - Day 8

  159. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11

    Measured: Treatment phase - Day 11

  160. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16

    Measured: Treatment phase - Day 16

  161. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24

    Measured: Treatment phase - Day 24

  162. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28

    Measured: Treatment phase - Day 28

  163. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8

    Measured: Follow-up phase - Week 8

  164. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12

    Measured: Follow-up phase - Week 12

  165. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16

    Measured: Follow-up phase - Week 16

  166. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24

    Measured: Follow-up phase - Week 24

  167. Participants With Grade 1 AST Level

    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28

    Measured: Follow-up phase - Week 28

  168. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1

    Measured: Treatment phase - Day 1

  169. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2

    Measured: Treatment phase - Day 2

  170. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3

    Measured: Treatment phase - Day 3

  171. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4

    Measured: Treatment phase - Day 4

  172. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5

    Measured: Treatment phase - Day 5

  173. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8

    Measured: Treatment phase - Day 8

  174. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11

    Measured: Treatment phase - Day 11

  175. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16

    Measured: Treatment phase - Day 16

  176. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24

    Measured: Treatment phase - Day 24

  177. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28

    Measured: Treatment phase - Day 28

  178. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8

    Measured: Follow-up phase - Week 8

  179. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12

    Measured: Follow-up phase - Week 12

  180. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16

    Measured: Follow-up phase - Week 16

  181. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20

    Measured: Follow-up phase - Week 20

  182. Participants With Grade 2 ALT Level

    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24

    Measured: Follow-up phase - Week 24

  183. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1

    Measured: Treatment phase - Day 1

  184. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2

    Measured: Treatment phase - Day 2

  185. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3

    Measured: Treatment phase - Day 3

  186. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4

    Measured: Treatment phase - Day 4

  187. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5

    Measured: Treatment phase - Day 5

  188. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8

    Measured: Treatment phase - Day 8

  189. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11

    Measured: Treatment phase - Day 11

  190. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16

    Measured: Treatment phase - Day 16

  191. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24

    Measured: Treatment phase - Day 24

  192. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28

    Measured: Treatment phase - Day 28

  193. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8

    Measured: Follow-up phase - Week 8

  194. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12

    Measured: Follow-up phase - Week 12

  195. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16

    Measured: Follow-up phase - Week 16

  196. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24

    Measured: Follow-up phase - Week 24

  197. Participants With Grade 2 AST Level

    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28

    Measured: Follow-up phase - Week 28

  198. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1

    Measured: Treatment phase - Day 1

  199. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2

    Measured: Treatment phase - Day 2

  200. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3

    Measured: Treatment phase - Day 3

  201. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4

    Measured: Treatment phase - Day 4

  202. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5

    Measured: Treatment phase - Day 5

  203. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8

    Measured: Treatment phase - Day 8

  204. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11

    Measured: Treatment phase - Day 11

  205. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16

    Measured: Treatment phase - Day 16

  206. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24

    Measured: Treatment phase - Day 24

  207. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28

    Measured: Treatment phase - Day 28

  208. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8

    Measured: Follow-up phase - Week 8

  209. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12

    Measured: Follow-up phase - Week 12

  210. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16

    Measured: Follow-up phase - Week 16

  211. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20

    Measured: Follow-up phase - Week 20

  212. Participants With Grade 3 ALT Level

    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24

    Measured: Follow-up phase - Week 24

  213. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1

    Measured: Treatment phase - Day 1

  214. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2

    Measured: Treatment phase - Day 2

  215. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3

    Measured: Treatment phase - Day 3

  216. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4

    Measured: Treatment phase - Day 4

  217. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5

    Measured: Treatment phase - Day 5

  218. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8

    Measured: Treatment phase - Day 8

  219. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11

    Measured: Treatment phase - Day 11

  220. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16

    Measured: Treatment phase - Day 16

  221. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24

    Measured: Treatment phase - Day 24

  222. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28

    Measured: Treatment phase - Day 28

  223. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8

    Measured: Follow-up phase - Week 8

  224. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12

    Measured: Follow-up phase - Week 12

  225. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16

    Measured: Follow-up phase - Week 16

  226. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24

    Measured: Follow-up phase - Week 24

  227. Participants With Grade 3 AST Level

    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28

    Measured: Follow-up phase - Week 28

  228. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 1

    Measured: Treatment phase - Day 1

  229. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 2

    Measured: Treatment phase - Day 2

  230. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 3

    Measured: Treatment phase - Day 3

  231. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 4

    Measured: Treatment phase - Day 4

  232. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 5

    Measured: Treatment phase - Day 5

  233. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 8

    Measured: Treatment phase - Day 8

  234. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 11

    Measured: Treatment phase - Day 11

  235. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 16

    Measured: Treatment phase - Day 16

  236. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 24

    Measured: Treatment phase - Day 24

  237. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 28

    Measured: Treatment phase - Day 28

  238. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 8

    Measured: Follow-up phase - Week 8

  239. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine aminotransferase (ALT) level at week 12

    Measured: Follow-up phase - Week 12

  240. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 16

    Measured: Follow-up phase - Week 16

  241. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 20

    Measured: Follow-up phase - Week 20

  242. Participants With Grade 4 ALT Level

    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 24

    Measured: Follow-up phase - Week 24

  243. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 1

    Measured: Treatment phase - Day 1

  244. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 2

    Measured: Treatment phase - Day 2

  245. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 3

    Measured: Treatment phase - Day 3

  246. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 4

    Measured: Treatment phase - Day 4

  247. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 5

    Measured: Treatment phase - Day 5

  248. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 8

    Measured: Treatment phase - Day 8

  249. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 11

    Measured: Treatment phase - Day 11

  250. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 16

    Measured: Treatment phase - Day 16

  251. Participants With Grade 4 AST Level

    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 24

    Measured: Treatment phase - Day 24

  252. Participants With Grade 4 AST Level

    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 28

    Measured: Treatment phase - Day 28

  253. Participants With Grade 4 AST Level

    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 8

    Measured: Follow-up phase - Week 8

  254. Participants With Grade 4 AST Level

    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 12

    Measured: Follow-up phase - Week 12

  255. Participants With Grade 4 AST Level

    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 16

    Measured: Follow-up phase - Week 16

  256. Participants With Grade 4 AST Level

    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 24

    Measured: Follow-up phase - Week 24

  257. Participants With Grade 4 AST Level

    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 28

    Measured: Follow-up phase - Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start1 Jul 2016
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02818582
Sponsor's protocol ID
999916137
Other IDs
16-I-N137
Status last verified
Oct 2019
First submitted
28 Jun 2016
Last updated
15 Feb 2022
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • de Vries DH, Rwemisisi JT, Musinguzi LK, Benoni TE, Muhangi D, de Groot M, Kaawa-Mafigiri D, Pool R. The first mile: community experience of outbreak control during an Ebola outbreak in Luwero District, Uganda. BMC Public Health. 2016 Feb 16;16:161. doi: 10.1186/s12889-016-2852-0.

    PubMed 26883621

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Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GS-5734 in people with Ebola, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Guinea, Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase (time frame: Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02818582, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

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