Phase 3b Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV 1 Infected Patients
This study will evaluate the non-inferiority of stribild (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate [EVG/COBI/FTC/TDF]) single-tablet regimen relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus truvada (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
Acquired Immunodeficiency Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) Plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients|
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 as defined by the FDA snapshot analysis [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
- Change from baseline in CD4+ cell count at Weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Participants will be randomized to switch to the Stribild® for 96 weeks.
Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food
Active Comparator: RTV-boosted PI+TVD
Participants will be randomized to remain on their current antiretroviral regimen consisting of an RTV-boosted PI plus TVD for 96 weeks.
Ritonavir (RTV) administered according to prescribing informationDrug: TVD
Truvada (TVD) administered according to prescribing information
Other Name: Truvada®Drug: PI
Protease inhibitors (PI) administered according to prescribing information, which may include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475838
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|Study Chair:||David Piontkowsky, JD, MD||Gilead Sciences|