CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 517 enrolled
Drug / intervention
Emtricitabine (FTC) +5 moredrug
Likely dose
Emtricitabine 200 mg once daily, Tenofovir disoproxil fumarate 300 mg once daily, and Efavirenz 600 mg once daily for 96 weeks; or Lamivudine/zidovudine 150/300 mg twice daily for 240 weeksAI-extracted
Key inclusion· 4
  • ✓HIV-1 RNA level greater than 10,000 c/mL
  • ✓Creatinine clearance ≥50 mL/min by Cockcroft-Gault
  • ✓Life expectancy ≥1 year
  • ✓Ability to understand and sign informed consent
Key exclusion· 6
  • ✕Prior treatment with any NNRTI, NRTI, or PI
  • ✕New AIDS-defining condition (except CD4 criteria) within 30 days of baseline
  • ✕Pregnant or lactating
  • ✕Malignancy other than cutaneous KS or basal cell carcinoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112047
NCT00112047Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Multicenter Study of the Treatment of Antiretroviral-Naive HIV-1 Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs Combivir (Lamivudine/Zidovudine) and Efavirenz

Gilead Sciences·interventional·Posted May 30, 2005·Updated Oct 13, 2010

In Brief

A Phase 3 clinical trial evaluating Emtricitabine (FTC), Tenofovir Disoproxil Fumarate (TDF), and 4 other interventions for HIV Infections. Completed, enrolled 517 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2005
Enrollment StartJul 1, 2003
Primary CompletionFeb 1, 2005
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 21.1 years ago

Interventions

Emtricitabine (FTC)drug

Capsule containing 200 mg FTC, taken once daily, for 96 weeks

Tenofovir Disoproxil Fumarate (TDF)drug

Tablet containing 300 mg TDF, taken once daily, for 96 weeks

Efavirenz (EFV)drug

Tablet containing 600 mg EFV, taken once daily, for 96 weeks

FTC/TDFdrug

Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144

FTC/TDF/EFVdrug

Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240

Lamivudine/zidovudinedrug

Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks