WAVESA Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

Fecha de inicio: 24 de octubre de 2012

Key Inclusion Criteria: Female (at birth), age ≥ 18 years Ability to understand and sign a written informed consent form Plasma HIV-1 RNA levels ≥ 500 copies/mL No prior use of any approved or investigational antiretroviral drug for any length of time Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV) Normal ECG Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula Hepatic transaminases ≤ 5 x upper limit of normal (ULN) Total bilirubin ≤ 1.5 mg/dL Adequate hematologic function Serum amylase ≤ 5 x ULN Women of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, or practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug Women 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. Key Exclusion Criteria: A new AIDS defining condition diagnosed within the 30 days Females receiving drug treatment for Hepatitis C, or females who are anticipated to receive treatment for Hepatitis C during the course of the study Females experiencing decompensated cirrhosis Females who are breastfeeding Positive serum pregnancy test (female of childbearing potential) Have an implanted defibrillator or pacemaker Have an ECG pulse rate interval ≥ 220 msec Current alcohol or substance use which may potentially interfere with the female's study compliance History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline Participation in any other clinical trial without prior approval Any other clinical condition or prior therapy that would make the female unsuitable for the study or unable to comply with the dosing requirements Females receiving ongoing therapy with any disallowed medications, including drugs not to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir capsules or ritonavir tablets Note: Other protocol defined Inclusion/Exclusion criteria may apply.