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NCT02121795 · ClinicalTrials.gov registry record · Phase 3
Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 668
- Enrollment target
NCT02121795: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02121795 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 668 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02121795, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 668 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.
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 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 F/TAF
- DRUG F/TAF Placebo
- DRUG FTC/TDF Placebo
- DRUG Allowed third antiretroviral agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 668 participants |
| Start Date | 2014-05-06 |
| Est. Completion | 2019-03-01 |
| Phase | Phase 3 |
What the finished NCT02121795 record still lists
NCT02121795 is an interventional study that assigns participants to a tested intervention. The registered 668 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 (13% lower).
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT02121795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02121795 about?
NCT02121795 is a clinical study titled "Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF". This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study wi...
What is the current status of trial NCT02121795?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 668 participants. The study started on 2014-05-06. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT02121795?
The interventions under investigation include: FTC/TDF (DRUG), F/TAF (DRUG), F/TAF Placebo (DRUG), FTC/TDF Placebo (DRUG), Allowed third antiretroviral agent (DRUG).
Who is sponsoring clinical trial NCT02121795?
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 NCT02121795's enrollment target sits among peer trials
668 548th of 2000 higher than 1,450 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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