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
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+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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : FTC/TDF
- drug : PI
- drug : RTV
- drug : Stribild
Phase: Phase 3
Ages Eligible For Study:
- Ability to understand and sign a written informed consent form - Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ? 6 consecutive months preceding the screening visit - Be on the first or second antiretroviral drug regimen documented undetectable plasma HIV 1 RNA levels for ? 6 months preceding the screening visit - No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time - Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC - HIV RNA < 50 copies/mL - Normal ECG - Hepatic transaminases ? 5 × the upper limit of the normal range (ULN) - Total bilirubin ? 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ? 5 × ULN - Estimated glomerular filtration rate ? 70 mL/min according to the Cockcroft-Gault formula - Females of childbearing potential must agree to utilize highly effective contraception methods, or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug - Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing - Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product, or must be non-heterosexually active, or practice sexual abstinence