Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF 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 efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.
Acquired Immunodeficiency Syndrome
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3B Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) Single-Tablet Regimen (STR) in Virologically Suppressed, HIV-1 Infected Patients|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities [ Time Frame: Up to 48 weeks plus 30 days ] [ Designated as safety issue: No ]This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Participants will switch to Stribild for 48 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533259
|United States, California|
|Peter J. Ruane, MD, Inc.|
|Los Angeles, California, United States, 90036|
|Kaiser Permanente Los Angeles|
|Los Angeles, California, United States, 90027|
|Anthony Mills MD, Inc|
|Los Angeles, California, United States, 90069|
|United States, District of Columbia|
|Capital Medical Associates, PC|
|Washington, District of Columbia, United States, 20036|
|Dupont Circle Physician's Group|
|Washington, District of Columbia, United States, 20009|
|United States, Florida|
|Orlando Immunology Center|
|Orlando, Florida, United States, 32803|
|United States, Massachusetts|
|Community Research Initiative of New England|
|Boston, Massachusetts, United States, 02215|
|United States, Texas|
|Central Texas Clinical Research|
|Austin, Texas, United States, 78705|
|Gordon E. Crofoot, MD, PA|
|Houston, Texas, United States, 77098|
|Study Director:||Huyen Cao, MD||Gilead Sciences|