Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112047
Status:
COMPLETED
Last Update Posted:
2010-10-13
First Post:
2005-05-27
Brief Title:
Tenofovir Disoproxil FumarateEmtricitabineEfavirenz Versus CombivirEfavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
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 LamivudineZidovudine and Efavirenz
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 copiesmL cmL through Week 48 as defined by the United States US Food and Drug Administration FDA time-to-loss-of-virologic-response TLOVR algorithm
Detailed Description:
This study was originally planned as a 48-week Phase 3 randomized open-label multicenter study comparing EFVFTCTDF administered as the individual component drugs versus CBV lamivudinezidovudine EFV to assess the efficacy and safety of both treatments in ART-Naive HIV-1 infected participants The regimen of CBV administered twice daily EFV administered once daily served as the active control treatment and was compared with the regimen of EFVFTCTDF each component drug in the EFVFTCTDF regimen was administered once daily
Week 48 to Week 96
The study was extended and continued to evaluate the efficacy and safety of the two regimens up to a total treatment duration of 96 weeks The regimen of EFVFTCTDF continued to be dosed as the component drugs EFV FTC TDF once daily without regard to meals The regimen of CBVEFV was dosed as 2 pills CBV twice daily in the morning without regard to meals EFV once daily without regard to meals
Week 96 to Week 144
A further study extension changed the 3-pill EFVFTCTDF regimen to a 2-pill regimen of EFV Truvada TVD a fixed-dose combination pill containing FTCTDF once daily without regard to meals and continued to evaluate the efficacy and safety of the two regimens for a further 48 weeks up to a total study treatment duration of 144 weeks The regimen of CBVEFV continued to be dosed as 2 pills CBV twice daily in the morning without regard to meals EFV once daily without regard to meals
Week 144 to end of study Week 240
A final study extension provided all study participants from both treatment regimens the option to switch their respective treatments to the 1-pill regimen of for a further 96 weeks up to a total study duration of 240 weeks 5 years to further assess the efficacy and safety of ART regimen simplification At sites in France the study was extended by a further 48 weeks Year 6 or until ATR became commercially available whichever happened first once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study
Week 48 to Week 96
The study was extended and continued to evaluate the efficacy and safety of the two regimens up to a total treatment duration of 96 weeks The regimen of EFVFTCTDF continued to be dosed as the component drugs EFV FTC TDF once daily without regard to meals The regimen of CBVEFV was dosed as 2 pills CBV twice daily in the morning without regard to meals EFV once daily without regard to meals
Week 96 to Week 144
A further study extension changed the 3-pill EFVFTCTDF regimen to a 2-pill regimen of EFV Truvada TVD a fixed-dose combination pill containing FTCTDF once daily without regard to meals and continued to evaluate the efficacy and safety of the two regimens for a further 48 weeks up to a total study treatment duration of 144 weeks The regimen of CBVEFV continued to be dosed as 2 pills CBV twice daily in the morning without regard to meals EFV once daily without regard to meals
Week 144 to end of study Week 240
A final study extension provided all study participants from both treatment regimens the option to switch their respective treatments to the 1-pill regimen of for a further 96 weeks up to a total study duration of 240 weeks 5 years to further assess the efficacy and safety of ART regimen simplification At sites in France the study was extended by a further 48 weeks Year 6 or until ATR became commercially available whichever happened first once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None