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NCT02607956 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 657
- Enrollment target
NCT02607956: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02607956 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 657 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02607956, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 657 participants
- Enrollment target
Study Summary
This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.
Primary Outcome
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.
Interventions
- DRUG B/F/TAF
- DRUG F/TAF
- DRUG F/TAF Placebo
- DRUG DTG
- DRUG DTG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 657 participants |
| Start Date | 2015-11-11 |
| Est. Completion | 2021-07-05 |
| Phase | Phase 3 |
What the finished NCT02607956 record still lists
NCT02607956 is an interventional study that assigns participants to a tested intervention. The registered 657 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 5 interventions - of which B/F/TAF is the first listed.
NCT02607956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02607956 about?
NCT02607956 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults". This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment...
What is the current status of trial NCT02607956?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 657 participants. The study started on 2015-11-11. Estimated completion is 2021-07-05.
What interventions are being tested in trial NCT02607956?
The interventions under investigation include: B/F/TAF (DRUG), F/TAF (DRUG), F/TAF Placebo (DRUG), DTG (DRUG), DTG Placebo (DRUG).
Who is sponsoring clinical trial NCT02607956?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02607956's enrollment target sits among peer trials
657 564th of 2000 higher than 1,436 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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