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NCT01565850 · ClinicalTrials.gov registry record · Phase 2
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
NCT01565850: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT01565850 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 153 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565850, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.
Primary Outcome
The snapshot algorithm was used which defines a patient'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 FTC/TDF
- DRUG DRV
- DRUG COBI
- DRUG D/C/F/TAF
- DRUG D/C/F/TAF Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
What the finished NCT01565850 record still lists
NCT01565850 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT01565850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01565850 about?
NCT01565850 is a clinical study titled "D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults". This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naiv...
What is the current status of trial NCT01565850?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2012-04. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01565850?
The interventions under investigation include: FTC/TDF (DRUG), DRV (DRUG), COBI (DRUG), D/C/F/TAF (DRUG), D/C/F/TAF Placebo (DRUG).
Who is sponsoring clinical trial NCT01565850?
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 NCT01565850's enrollment target sits among peer trials
153 449th of 2000 higher than 1,549 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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