D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

Exclusion Criteria

• •A new AIDS defining condition diagnosed within the 30 days prior to screening
• •Hepatitis B surface antigen positive
• •Hepatitis C antibody positive
• •Proven acute hepatitis in the 30 days prior to study entry
• •Have a history or experiencing decompensated cirrhosis
• •Current alcohol or substance use that potentially interferes with study compliance
• •Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
• •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
• •Females who are breastfeeding
• •Positive serum pregnancy test (female of childbearing potential)
• •Female subjects who utilize non-estrogen hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
• •Have an implanted defibrillator or pacemaker
• •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
• •Participation in any other clinical trial without prior approval is prohibited while participating in this trial
• •Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with darunavir and cobicistat
• •Note: darunavir is a sulfonamide. Participants who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and darunavir has been identified in patients participating in Phase 2 and Phase 3 trials.