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NCT02603107 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 578
- Enrollment target
NCT02603107: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02603107 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 578 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02603107, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 578 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.
Primary Outcome
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.
Interventions
- DRUG ATV
- DRUG DRV
- DRUG RTV
- DRUG COBI
- DRUG ATV/co
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 578 participants |
| Start Date | 2015-11-20 |
| Est. Completion | 2019-12-23 |
| Phase | Phase 3 |
What the finished NCT02603107 record still lists
NCT02603107 is an interventional study that assigns participants to a tested intervention. The registered 578 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 (25% lower).
The record links to 0 conditions, and to 5 interventions - of which ATV is the first listed.
NCT02603107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02603107 about?
NCT02603107 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults". The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir dis...
What is the current status of trial NCT02603107?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 578 participants. The study started on 2015-11-20. Estimated completion is 2019-12-23.
What interventions are being tested in trial NCT02603107?
The interventions under investigation include: ATV (DRUG), DRV (DRUG), RTV (DRUG), COBI (DRUG), ATV/co (DRUG).
Who is sponsoring clinical trial NCT02603107?
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 NCT02603107's enrollment target sits among peer trials
578 661st of 2000 higher than 1,340 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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