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NCT00112047 · ClinicalTrials.gov registry record · Phase 3
Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 517
- Enrollment target
NCT00112047: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00112047 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 517 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00112047, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 517 participants
- Enrollment target
Study Summary
The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF) in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the treatment of HIV-1 infected ART-naive participants, determined by the achievement and maintenance of confirmed HIV-1 ribonucleic acid (RNA) \< 400 copies/mL (c/mL) through Week 48, as defined by the United States (US) Food and Drug Administration (FDA) time-to-loss-of-virologic-response (TLOVR) algorithm.
Primary Outcome
Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL af
Interventions
- DRUG FTC/TDF
- DRUG Efavirenz (EFV)
- DRUG Emtricitabine (FTC)
- DRUG Tenofovir Disoproxil Fumarate (TDF)
- DRUG FTC/TDF/EFV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2003-07 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00112047 record still lists
NCT00112047 is an interventional study that assigns participants to a tested intervention. The registered 517 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 (33% lower).
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT00112047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00112047 about?
NCT00112047 is a clinical study titled "Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects". The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and ...
What is the current status of trial NCT00112047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2003-07. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00112047?
The interventions under investigation include: FTC/TDF (DRUG), Efavirenz (EFV) (DRUG), Emtricitabine (FTC) (DRUG), Tenofovir Disoproxil Fumarate (TDF) (DRUG), FTC/TDF/EFV (DRUG).
Who is sponsoring clinical trial NCT00112047?
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 NCT00112047's enrollment target sits among peer trials
517 724th of 2000 higher than 1,277 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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