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 experienced study to evaluate the efficacy of switching to a fixed dose combination (FDC) of GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adult subjects who are virologically suppressed. This is a 48 week study.
Who may be Eligible
Adults age 18 years or older; Currently receiving antiretroviral regimen containing ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for = 6 consecutive months prior to screening; Plasma HIV-1 RNA levels <50 copies/mL for at least 6 months prior to the screening visit and at the screening visit; normal ECG; normal maintenance lab values; not pregnant or nursinig or planning to become pregnant during the trial or considering fathering a child while on treatment; Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study dosing; not hepatitis C positive; no implanted defirbrillator or pacemaker; no history of malignancy within the past 5 years; 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 anyof the study agents at any time in the past; Serum amylast = 5 x ULN (subjects with serum amylase >5 X ULN will remain eligible if Serum lipase is =5 X ULN); Adequate renal function, life expantancy > 1 year.