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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 799 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01309243
The ClinicalTrials.gov registry entry for NCT01309243 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 799 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which FTC/RPV/TDF is the first listed.
NCT01309243 reports 0 study locations.
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.
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