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NCT01815736 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,443
- Enrollment target
NCT01815736: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01815736 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 1,443 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815736, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,443 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.
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 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 ATV
- DRUG E/C/F/TAF
- DRUG RTV
- DRUG E/C/F/TDF
- DRUG EFV/FTC/TDF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,443 participants |
| Start Date | 2013-03-27 |
| Est. Completion | 2020-04-01 |
| Phase | Phase 3 |
What the finished NCT01815736 record still lists
NCT01815736 is an interventional study that assigns participants to a tested intervention. Its 1,443 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% higher).
The record links to 0 conditions, and to 5 interventions - of which ATV is the first listed.
NCT01815736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01815736 about?
NCT01815736 is a clinical study titled "Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants". The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participan...
What is the current status of trial NCT01815736?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,443 participants. The study started on 2013-03-27. Estimated completion is 2020-04-01.
What interventions are being tested in trial NCT01815736?
The interventions under investigation include: ATV (DRUG), E/C/F/TAF (DRUG), RTV (DRUG), E/C/F/TDF (DRUG), EFV/FTC/TDF (DRUG).
Who is sponsoring clinical trial NCT01815736?
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 NCT01815736's enrollment target sits among peer trials
1,443 167th of 2000 higher than 1,834 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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