A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

NCT01475838 Phase 3 COMPLETED Results posted

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) 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.

Details

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	COMPLETED
Enrolment	438
Start date	2011-11
Completion	2014-12

Conditions

• Acquired Immunodeficiency Syndrome
• HIV Infections

Interventions

• PI
• RTV
• FTC/TDF
• Stribild

Primary outcomes

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 — Week 48
  The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Countries

United States, Austria, Belgium, Canada, France, Germany, Italy, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom