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NCT02397694 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT02397694: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT02397694 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397694, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.
Primary Outcome
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.
Interventions
- DRUG F/TAF
- DRUG DTG
- DRUG DTG Placebo
- DRUG BIC
- DRUG BIC Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2015-03-23 |
| Est. Completion | 2019-02-27 |
| Phase | Phase 2 |
What the finished NCT02397694 record still lists
NCT02397694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 5 interventions - of which F/TAF is the first listed.
NCT02397694 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02397694 about?
NCT02397694 is a clinical study titled "Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults". This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic...
What is the current status of trial NCT02397694?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2015-03-23. Estimated completion is 2019-02-27.
What interventions are being tested in trial NCT02397694?
The interventions under investigation include: F/TAF (DRUG), DTG (DRUG), DTG Placebo (DRUG), BIC (DRUG), BIC Placebo (DRUG).
Who is sponsoring clinical trial NCT02397694?
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 NCT02397694's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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