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Carolinas HealthCare System

Research and Clinical Trials

Title  
GS-US-380-1489
Brief Description  
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.
Start Date  
02/01/2016
IRB Number  
01-16-26B
Principal Investigator  
Polk, Christopher
Contact Name  
Lisa

For More Information, Contact   Lisa  Engle
Phone:  (704) 667-5324  Fax:  (704) 331-9266 
Email:  Lisa.engel@carolinashealthcare.org
Address:  4539 Hedgemore Drive, Suite 100
Charlotte, NC 28209
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