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NCT01309243 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 799
- Enrollment target
NCT01309243: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01309243 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 799 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01309243, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 799 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.
Primary Outcome
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Interventions
- DRUG FTC/RPV/TDF
- DRUG EFV/FTC/TDF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 799 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01309243 record still lists
NCT01309243 is an interventional study that assigns participants to a tested intervention. The registered 799 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which FTC/RPV/TDF is the first listed.
NCT01309243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01309243 about?
NCT01309243 is a clinical study titled "Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults". The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretr...
What is the current status of trial NCT01309243?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 799 participants. The study started on 2011-02. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01309243?
The interventions under investigation include: FTC/RPV/TDF (DRUG), EFV/FTC/TDF (DRUG).
Who is sponsoring clinical trial NCT01309243?
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 NCT01309243's enrollment target sits among peer trials
799 428th of 2000 higher than 1,573 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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