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NCT02345252 · ClinicalTrials.gov registry record · Phase 3
Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 632
- Enrollment target
NCT02345252: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02345252 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 632 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02345252, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 632 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.
Primary Outcome
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, 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/RPV/TDF
- DRUG FTC/RPV/TAF
- DRUG FTC/RPV/TAF Placebo
- DRUG FTC/RPV/TDF Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 632 participants |
| Start Date | 2015-01-26 |
| Est. Completion | 2019-01-09 |
| Phase | Phase 3 |
What the finished NCT02345252 record still lists
NCT02345252 is an interventional study that assigns participants to a tested intervention. The registered 632 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 (18% lower).
The record links to 0 conditions, and to 4 interventions - of which FTC/RPV/TDF is the first listed.
NCT02345252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02345252 about?
NCT02345252 is a clinical study titled "Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)". The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 ...
What is the current status of trial NCT02345252?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 632 participants. The study started on 2015-01-26. Estimated completion is 2019-01-09.
What interventions are being tested in trial NCT02345252?
The interventions under investigation include: FTC/RPV/TDF (DRUG), FTC/RPV/TAF (DRUG), FTC/RPV/TAF Placebo (DRUG), FTC/RPV/TDF Placebo (DRUG).
Who is sponsoring clinical trial NCT02345252?
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 NCT02345252's enrollment target sits among peer trials
632 581st of 2000 higher than 1,420 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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