Patient & Visitor Alert: Because flu cases are on the rise, starting February 24, children 12 and younger will be restricted from visiting hospitals and certain inpatient facilities throughout Carolinas HealthCare System. Learn more.
HIV treatment-naïve study to evaluate safety and efficacy of a fixed dose combination (FDC) containing GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naïve-adult subjects. This is a 96 week study.
Who may be Eligible
Adults age 18 years or older; antiretroviral treatment naïve (=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for PrEP or PEP up to one month prior to screening; Plasma HIV-1 RNA levels =500 copies/mL at the screening visit; normal ECG; normal maintenance lab values; not pregnant or nursing or planning to become pregnant during the trial or considering fathering a child while on treatment. Male subjects must agree to refrain from using sperm donation from first study drug dose until at least 90 days following the last study drug dose; female subjects who utilize hormonal contraceptive as one of their birth control methods must hve used the same method for at least threemonths prior to study dosing; no chronic hepatitis B virus (HBV) infection as determined by either Positive HBV surface antibody, regardless of HBV surface antigen status, at the screening visit; negative screening test for HLA-B*5701 allele; screening genotype report must show sensitivity to FTC, TFG, 3TC, and ABC; no active serious infections other than HIV; no participation in other clinical trials; not taking one of a list of disallowed medications; no documented resistance to any of the study agents at any time in the past; serum amylase =5 x ULN (subjects with serum amylase >5 ULN will remain eligible if serum lipase is =5 x ULN); adequate renal function; life expentancy >1 year; screening genotype report must show sensitivity to FTC, TFV, 3TC, and ABC.