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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 517 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00112047
The ClinicalTrials.gov registry entry for NCT00112047 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 517 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 5 interventions - of which FTC/TDF is the first listed.
NCT00112047 reports 0 study locations.
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.
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