HIVPhase 3NCT01967940
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
A Phase 3 study testing TAF, E/C/F/TAF and Current failing ARV regimen in people with HIV and HIV Infections, run by Gilead Sciences at 15 sites in 5 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections, Acquired Immunodeficiency Syndrome
- What is being tested?
- TAF, E/C/F/TAF and Current failing ARV regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 25 Oct 2013to 31 Jul 2017
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Currently taking a failing ARV regimen
- Plasma HIV-1 RNA ≥ 500 copies/mL but ≤ 100,000 copies/mL at screening
- Normal ECG
- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- Alanine aminotransferase (AST)/aspartate aminotransferase (AST) ≤ 5 × the upper limit of the normal range (ULN)
Show all 16Show fewer
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Females may enter the study if it is confirmed that she is:
- Not pregnant or nursing
- Of non-childbearing potential (ie, have had a hysterectomy, both ovaries removed, medically documented ovarian failure, or are postmenopausal women > 54 years of age with cessation [for ≥ 12 months] of previously occurring menses), or
- Of childbearing potential and agrees to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following study drug dosing
- Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
- Males must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
- Males must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.
Who cannot join
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive (individuals with positive hepatitis C virus (HCV) antibody and without detectable HCV RNA are permitted to enroll)
- History of integrase inhibitor use
- Screening or historical genotype reports shows Q151M or T69ins or more than 3 TAMs.
- Screening or historical genotype report shows resistance to integrase inhibitors
Show all 14Show fewer
- Individuals experiencing decompensated cirrhosis
- Current alcohol or substance use
- History of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Part 1, Day 1 and must not be anticipated to require systemic therapy during the study.
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Part 1, Day 1
- Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with dosing requirements
- Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
- Receiving ongoing therapy with any disallowed medications, including any drugs not to be used with elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or known allergies to the excipients of E/C/F/TAF STR
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States5 sites
Midway Immunology and Research center
Ft. Pierce, Florida, 34982
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33401
Rowan Tree Medical, P.A.
Wilton Manors, Florida, 33305
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Thailand5 sites
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330
Ramathibodi Hospital, Mahidol University
Bangkok, 10400
Siriraj Hospital Department of Preventive and Social Medicine, Faculty of Medicine
Bangkok, 10700
Chiang Mai University
Chiang Mai, 50200
Khon Kaen University
Khon Kaen, 40002
Dominican Republic2 sites
Salvador B Gautier Hospital - Infectious Diseases Department
Santo Domingo, 10514
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo
Russia2 sites
Regional state budget health agency Krasnoyarsk Regional Center for Prevention and Control of AIDS
Krasnoyarsk, 660049
Center For Prevention and Treatment of AIDS and Infectious Diseases, Saint Petersburg
Saint Petersburg, 190020
About this study
Official title: A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2.
Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen.
In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.
- Conditions
- HIV, HIV Infections, Acquired Immunodeficiency Syndrome
- Being tested
- TAF, Placebo, E/C/F/TAF, Current failing ARV regimen, ATV
- Keywords
- HIV-1, HIV, Treatment-Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAFDrug
Also called Vemlidy®, GS-7340
25 mg tablet administered orally once daily with food
PlaceboDrug
Tablets to match TAF administered orally once daily with food
E/C/F/TAFDrug
Also called Genvoya®
150/150/200/10 mg STR administered orally once daily with food
Current failing ARV regimenDrug
Participants will continue taking their current ARV regimen as prescribed in Part 1.
ATVDrug
Also called Reyataz®
300 mg tablet administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Sentinel Cohort (TAF) | Experimental | TAF + their current failing ARV regimen for 10 days in Part 1 Receives: Drug: TAF; Drug: Current failing ARV regimen |
| Part 1 Randomized Cohort (TAF) | Experimental | Following review of safety and efficacy data from the Sentinel Cohort, participants will be randomized to receive TAF + their current failing ARV regimen for 10 days in Part 1. Receives: Drug: TAF; Drug: Current failing ARV regimen |
| Part 1 Randomized Cohort (Placebo) | Placebo comparator | Following review of safety and efficacy data from the Sentinel Cohort, participants will be randomized to receive placebo + their current failing ARV regimen for 10 days in Part 1. Receives: Drug: Placebo; Drug: Current failing ARV regimen |
| Part 2 E/C/F/TAF+ATV | Experimental | Following a 14-day period to confirm eligibility, participants in the Randomized Cohort TAF group with a > 0.5 log10 decline in HIV-1 RNA and all participants completing the Randomized Cohort Placebo group will receive E/C/F/TAF+ATV for 48 weeks in Part 2. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country. Receives: Drug: E/C/F/TAF; Drug: ATV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10
Measured: Day 10
Secondary outcomes (15)
Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10
Measured: Baseline; Day 10
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24
Measured: Up to Week 24
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48
Measured: Up to Week 48
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24
Measured: Up to Week 24
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48
Measured: Up to Week 48
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
The percentage of participants with 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
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
The percentage of participants with 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
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
The percentage of participants with 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
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
The percentage of participants with 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
Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24
Measured: Baseline; Week 24
Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48
Measured: Baseline; Week 48
Part 2: Change From Baseline in CD4+ Cell Count at Week 24
Measured: Baseline; Week 24
Part 2: Change From Baseline in CD4+ Cell Count at Week 48
Measured: Baseline; Week 48
Part 2: Change From Baseline in CD4+ Percentage at Week 24
Measured: Baseline; Week 24
Part 2: Change From Baseline in CD4+ Percentage at Week 48
Measured: Baseline; Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study start25 Oct 2013
- Primary completion21 May 2015
- Study completion31 Jul 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 HIVStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 (Sentinel Cohort followed by a Randomized Cohort), 14-day washout period, then Part 2
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 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
- NCT01967940
- Sponsor's protocol ID
- GS-US-292-0117
- Other IDs
- 2013-002830-19
- Status last verified
- Jul 2018
- First submitted
- 18 Oct 2013
- Last updated
- 16 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
- ClinicalTrials.gov ID
- NCT01967940
- Acronym / sponsor ID
- GS-US-292-0117
- Conditions
- HIV, HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- HIV-1, HIV, Treatment-Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2013 (actual)
- Primary completion
- 21 May 2015 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Posted 12 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2.
Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen.
In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Part 1 (Sentinel Cohort followed by a Randomized Cohort), 14-day washout period, then Part 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Sentinel Cohort (TAF) | Experimental | Drug: TAF, Drug: Current failing ARV regimenTAF + their current failing ARV regimen for 10 days in Part 1 |
| Part 1 Randomized Cohort (TAF) | Experimental | Drug: TAF, Drug: Current failing ARV regimenFollowing review of safety and efficacy data from the Sentinel Cohort, participants will be randomized to receive TAF + their current failing ARV regimen for 10 days in Part 1. |
| Part 1 Randomized Cohort (Placebo) | Placebo comparator | Drug: Placebo, Drug: Current failing ARV regimenFollowing review of safety and efficacy data from the Sentinel Cohort, participants will be randomized to receive placebo + their current failing ARV regimen for 10 days in Part 1. |
| Part 2 E/C/F/TAF+ATV | Experimental | Drug: E/C/F/TAF, Drug: ATVFollowing a 14-day period to confirm eligibility, participants in the Randomized Cohort TAF group with a > 0.5 log10 decline in HIV-1 RNA and all participants completing the Randomized Cohort Placebo group will receive E/C/F/TAF+ATV for 48 weeks in Part 2. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Currently taking a failing ARV regimen
- Plasma HIV-1 RNA ≥ 500 copies/mL but ≤ 100,000 copies/mL at screening
- Normal ECG
- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Key exclusion criteria (14 listed)
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive (individuals with positive hepatitis C virus (HCV) antibody and without detectable HCV RNA are permitted to enroll)
- History of integrase inhibitor use
- Screening or historical genotype reports shows Q151M or T69ins or more than 3 TAMs.
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 |
|---|---|---|
| TAFAlso: Vemlidy®, GS-734025 mg tablet administered orally once daily with food | Drug | Part 1 Randomized Cohort (TAF), Part 1 Sentinel Cohort (TAF) |
| PlaceboTablets to match TAF administered orally once daily with food | Drug | Part 1 Randomized Cohort (Placebo) |
| E/C/F/TAFAlso: Genvoya®150/150/200/10 mg STR administered orally once daily with food | Drug | Part 2 E/C/F/TAF+ATV |
| Current failing ARV regimenParticipants will continue taking their current ARV regimen as prescribed in Part 1. | Drug | Part 1 Randomized Cohort (Placebo), Part 1 Randomized Cohort (TAF), Part 1 Sentinel Cohort (TAF) |
| ATVAlso: Reyataz®300 mg tablet administered orally once daily. | Drug | Part 2 E/C/F/TAF+ATV |
Primary outcome
Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10
Time frame: Day 10
15 secondary outcomes
Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10
Time frame: Baseline; Day 10
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24
Time frame: Up to Week 24
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48
Time frame: Up to Week 48
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24
Time frame: Up to Week 24
Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48
Time frame: Up to Week 48
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
Time frame: Week 24
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
Time frame: Week 48
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24
Time frame: Week 24
Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48
Time frame: Week 48
Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24
Time frame: Baseline; Week 24
Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48
Time frame: Baseline; Week 48
Part 2: Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline; Week 24
Part 2: Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Part 2: Change From Baseline in CD4+ Percentage at Week 24
Time frame: Baseline; Week 24
Part 2: Change From Baseline in CD4+ Percentage at Week 48
Time frame: Baseline; Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
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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
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAF, E/C/F/TAF and Current failing ARV regimen in people with HIV and HIV Infections, run by Gilead Sciences at 15 sites in 5 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 16 inclusion and 14 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Thailand, Dominican Republic, Russia, Uganda. 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 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 12 Jun 2017). 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?
Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10 (time frame: Day 10). 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 16 Nov 2018.