Acquired Immune Deficiency Syndrome (AIDS)Phase 2/3NCT01923311
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
A Phase 2/3 study testing EVG and Background regimen in people with Acquired Immune Deficiency Syndrome (AIDS) and HIV Infections, run by Gilead Sciences at 11 sites in 6 countries.
Trial summary
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age. The study consists of 2 parts: Part A and Part B. Read more about this study
- Who is it for?
- Ages 4 weeks to 17 years
- Conditions the study is for
- Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
- What is being tested?
- EVG and Background regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 26 Aug 2013to 3 Nov 2017
- Phase
- Phase 2/3
- 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 4 weeks to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Individuals must meet all of the following inclusion criteria to be eligible for participation in this study. Individuals with screening results that do not meet eligibility criteria will not be allowed to rescreen.
- HIV-1 infected male and female individuals 4 weeks (gestational age of at least 44 weeks) to less than 18 years of age at Baseline.
- Individuals are able to provide written assent if they have the ability to read and write.
- Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements.
- Body weight at screening greater than 5kg, 10.6kg, or 15kg dependent upon age cohort
- Adequate renal function
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- Adequate hematologic function
- Hepatic transaminases (AST and ALT) less than or equal to 5 x upper limit of normal (ULN)
- Total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin
- Negative serum pregnancy test
- Individuals with evidence of suppressed viremia
- Individuals failing a current antiretroviral regimen at study entry
- Male and female individuals of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse of reproductive potential throughout the study period and for 30 days following the last dose of study drug
- Must be willing and able to comply with all study requirements.
Who cannot join
- Participants who meet any of the following exclusion criteria are not to be enrolled in this study.
- Individuals with CD4+ cell counts at Screening of less than 50, 75, or 200 cells/mm3 dependent on age cohort
- An AIDS defining condition with onset within 30 days prior to screening
- Life expectancy of less than 1 year
- For Individuals with HIV-1 RNA greater than 1,000 copies/mL at screening, prior treatment of any duration with an integrase strand transfer inhibitor.
- An ongoing serious infection requiring systemic antibiotic therapy at the time of screening.
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- Evidence of active pulmonary or extra-pulmonary tuberculosis disease
- Anticipated requirement for rifamycin treatment while participating in the study.
- Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with Individual's treatment, assessment, or compliance with the protocol.
- Individuals experiencing decompensated cirrhosis
- A history of or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
- Pregnant or lactating females.
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with individual's compliance.
- Have history of significant drug sensitivity or drug allergy.
- Known hypersensitivity to the study drug, the metabolites, or formulation excipients.
- Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing.
- Participation in any other clinical trial without prior approval from sponsor is prohibited while participating in this trial.
- Individuals receiving ongoing therapy with any medication that is not to be taken with EVG or a component of the BR, including drugs not to be used with ritonavir
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United States3 sites
University of Colorado Denver
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
South Africa2 sites
Be Part Yoluntu Centre
Cape Town, 7646
Rahima Moosa Mother and Child Hopsital
Johannesburg, 2112
Spain2 sites
Hospital Universitario De Getafe
Getafe, Madrid, 28095
Hospital 12 de Octubre
Madrid, 28041
Thailand2 sites
Thai Red Cross AIDS Research Centre (HIV-NAT)
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Italy1 site
Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
About this study
Official title: A Phase 2/3 Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered With a Background-Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current antiretroviral (ARV) regimen (HIV-1 RNA > 1,000 copies/mL only for participants in Cohort 2, Part A) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG. The study consists of 4 age cohorts with each cohort including 2 parts (Part A and Part B) with the exception of the adolescent age cohort (Cohort 1: 12 to < 18 years old) containing Part B only.
- Being tested
- EVG, Background regimen
- Keywords
- Pediatrics, Adolescents, HIV, HIV-1, Treatment-experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVGDrug
Also called Vitekta®
Tablet (s) or tablet (s) for oral suspension (if unable to swallow) will be administered orally once daily
Background regimenDrug
Background regimen may consist of the following ritonavir (RTV)-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (12 to < 18 years of age) | Experimental | Part A: No participants will be enrolled in Part A, as PK data is currently available for this age group.
Part B: Participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. After Week 48, participants will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. Receives: Drug: EVG; Drug: Background regimen |
| Cohort 2 (6 to < 12 years of age) | Experimental | Part A: Participants with HIV-1 RNA < 50 copies/mL will receive EVG plus a background regimen that includes a PI/r for 10 days. Participants with HIV-1 RNA > 1,000 copies/mL will receive EVG along with a newly constructed background regimen that includes a Pl/r for 48 weeks. Participants with HIV-1 RNA > 1,000 copies/mL can continue after Week 48.
Part B: Following confirmation of exposure to EVG and based on safety and PK data assessed in Part A, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. Participants who complete the 48-week follow-up in both Part A and Part B will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. Receives: Drug: EVG; Drug: Background regimen |
| Cohort 3 (2 to < 6 years of age) | Experimental | Part A: Participants with HIV-1 RNA < 50 copies/mL will receive EVG plus a background regimen that includes a PI/r for 10 days.
Part B: Following confirmation of exposure to EVG and based on safety and PK data assessed in Part A, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. After Week 48, participants will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. Receives: Drug: EVG; Drug: Background regimen |
| Cohort 4 (4 weeks to < 2 years of age) | Experimental | Part A: Participants with HIV-1 RNA < 50 copies/mL will receive EVG plus a background regimen that includes a PI/r for 10 days.
Part B: Following confirmation of exposure to EVG and based on safety and PK data assessed in Part A, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. After Week 48, participants will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. Receives: Drug: EVG; Drug: Background regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) Parameter: AUCtau of EVG
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: Predose and up to 12 hours postdose on Day 10
Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10
Cmax is defined as the maximum concentration of drug.
Measured: Predose and up to 12 hours postdose on Day 10
Percentage of Participants Experiencing Treatment-emergent Adverse Events
Measured: Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Percentage of Participants Experiencing Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject. The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).
Measured: Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Secondary outcomes (18)
Pharmacokinetic (PK) Parameter: Ctau of EVG
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: Predose and up to 12 hours postdose on Day 10
Pharmacokinetic (PK) Parameter: CL/F of EVG
CL/F is defined as the apparent oral clearance following administration of the drug.
Measured: Predose and up to 12 hours postdose on Day 10
Pharmacokinetic (PK) Parameter: Vz/F of EVG
Vz/F is defined as the apparent volume of distribution of the drug.
Measured: Predose and up to 12 hours postdose on Day 10
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Measured: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Measured: Week 48
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Measured: Week 24
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Measured: Week 48
Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24
Measured: Baseline to Week 24
Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48
Measured: Baseline to Week 48
Change From Baseline in CD4 Cell Count at Week 24
Measured: Baseline to Week 24
Change From Baseline in CD4 Cell Count at Week 48
Measured: Baseline to Week 48
Change From Baseline in CD4 Percentage at Week 24
Measured: Baseline to Week 24
Change From Baseline in CD4 Percentage at Week 48
Measured: Baseline to Week 48
Tanner Stage Evaluation by Sex at Week 24
Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 24 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).
Measured: Week 24
Tanner Stage Evaluation by Sex at Week 48
Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 48 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).
Measured: Week 48
Age of First Menses
Age of first menses for female participants.
Measured: Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL)
Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group
Measured: Up to Week 48
Adherence to EVG
Adherence was calculated as the number of pills taken divided by number of pills prescribed multiplied by 100.
Measured: Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study start26 Aug 2013
- Primary completion3 Nov 2017
- Study completion3 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acquired Immune Deficiency Syndrome (AIDS)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923311
- Sponsor's protocol ID
- GS-US-183-0160
- Other IDs
- 2013-001969-16
- Status last verified
- Jul 2018
- First submitted
- 9 Aug 2013
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered With a Background-Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects
- ClinicalTrials.gov ID
- NCT01923311
- Acronym / sponsor ID
- GS-US-183-0160
- Keywords
- Pediatrics, Adolescents, HIV, HIV-1, Treatment-experienced
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2013 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current antiretroviral (ARV) regimen (HIV-1 RNA > 1,000 copies/mL only for participants in Cohort 2, Part A) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG. The study consists of 4 age cohorts with each cohort including 2 parts (Part A and Part B) with the exception of the adolescent age cohort (Cohort 1: 12 to < 18 years old) containing Part B only.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (12 to < 18 years of age) | Experimental | Drug: EVG, Drug: Background regimenPart A: No participants will be enrolled in Part A, as PK data is currently available for this age group. Part B: Participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. After Week 48, participants will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. |
| Cohort 2 (6 to < 12 years of age) | Experimental | Drug: EVG, Drug: Background regimenPart A: Participants with HIV-1 RNA < 50 copies/mL will receive EVG plus a background regimen that includes a PI/r for 10 days. Participants with HIV-1 RNA > 1,000 copies/mL will receive EVG along with a newly constructed background regimen that includes a Pl/r for 48 weeks. Participants with HIV-1 RNA > 1,000 copies/mL can continue after Week 48. Part B: Following confirmation of exposure to EVG and based on safety and PK data assessed in Part A, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. Participants who complete the 48-week follow-up in both Part A and Part B will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. |
| Cohort 3 (2 to < 6 years of age) | Experimental | Drug: EVG, Drug: Background regimenPart A: Participants with HIV-1 RNA < 50 copies/mL will receive EVG plus a background regimen that includes a PI/r for 10 days. Part B: Following confirmation of exposure to EVG and based on safety and PK data assessed in Part A, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. After Week 48, participants will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. |
| Cohort 4 (4 weeks to < 2 years of age) | Experimental | Drug: EVG, Drug: Background regimenPart A: Participants with HIV-1 RNA < 50 copies/mL will receive EVG plus a background regimen that includes a PI/r for 10 days. Part B: Following confirmation of exposure to EVG and based on safety and PK data assessed in Part A, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks. After Week 48, participants will be given the option to continue EVG therapy until the participant turns 18 and EVG is available for use in adults in the country in which the participant is enrolled, or the age appropriate EVG formulation becomes available for use in the country in which the participant is enrolled, or Gilead Sciences elects to terminate development of EVG in the applicable country. |
Who may qualify
- Ages
- 4 weeks to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Individuals must meet all of the following inclusion criteria to be eligible for participation in this study. Individuals with screening results that do not meet eligibility criteria will not be allowed to rescreen.
- HIV-1 infected male and female individuals 4 weeks (gestational age of at least 44 weeks) to less than 18 years of age at Baseline.
- Individuals are able to provide written assent if they have the ability to read and write.
- Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements.
- Body weight at screening greater than 5kg, 10.6kg, or 15kg dependent upon age cohort
Key exclusion criteria (19 listed)
- Participants who meet any of the following exclusion criteria are not to be enrolled in this study.
- Individuals with CD4+ cell counts at Screening of less than 50, 75, or 200 cells/mm3 dependent on age cohort
- An AIDS defining condition with onset within 30 days prior to screening
- Life expectancy of less than 1 year
- For Individuals with HIV-1 RNA greater than 1,000 copies/mL at screening, prior treatment of any duration with an integrase strand transfer inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVGAlso: Vitekta®Tablet (s) or tablet (s) for oral suspension (if unable to swallow) will be administered orally once daily | Drug | Cohort 1 (12 to < 18 years of age), Cohort 2 (6 to < 12 years of age), Cohort 3 (2 to < 6 years of age), Cohort 4 (4 weeks to < 2 years of age) |
| Background regimenBackground regimen may consist of the following ritonavir (RTV)-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed. | Drug | Cohort 1 (12 to < 18 years of age), Cohort 2 (6 to < 12 years of age), Cohort 3 (2 to < 6 years of age), Cohort 4 (4 weeks to < 2 years of age) |
Primary outcome
Pharmacokinetic (PK) Parameter: AUCtau of EVG
Time frame: Predose and up to 12 hours postdose on Day 10
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10
Time frame: Predose and up to 12 hours postdose on Day 10
Cmax is defined as the maximum concentration of drug.
Percentage of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject. The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).
18 secondary outcomes
Pharmacokinetic (PK) Parameter: Ctau of EVG
Time frame: Predose and up to 12 hours postdose on Day 10
Pharmacokinetic (PK) Parameter: CL/F of EVG
Time frame: Predose and up to 12 hours postdose on Day 10
Pharmacokinetic (PK) Parameter: Vz/F of EVG
Time frame: Predose and up to 12 hours postdose on Day 10
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
Time frame: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
Time frame: Week 24
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
Time frame: Week 48
Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24
Time frame: Baseline to Week 24
Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48
Time frame: Baseline to Week 48
Change From Baseline in CD4 Cell Count at Week 24
Time frame: Baseline to Week 24
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline to Week 48
Change From Baseline in CD4 Percentage at Week 24
Time frame: Baseline to Week 24
Change From Baseline in CD4 Percentage at Week 48
Time frame: Baseline to Week 48
Tanner Stage Evaluation by Sex at Week 24
Time frame: Week 24
Tanner Stage Evaluation by Sex at Week 48
Time frame: Week 48
Age of First Menses
Time frame: Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL)
Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group
Time frame: Up to Week 48
Adherence to EVG
Time frame: Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EVG and Background regimen in people with Acquired Immune Deficiency Syndrome (AIDS) and HIV Infections, run by Gilead Sciences at 11 sites in 6 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 14 inclusion and 19 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: stopped early, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, South Africa, Spain, Thailand, Italy and 1 more country. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Jul 2018). 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?
Pharmacokinetic (PK) Parameter: AUCtau of EVG (time frame: Predose and up to 12 hours postdose on Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2018.