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Carolinas HealthCare System

Research and Clinical Trials

Title  
GS-US-380-1878
Brief Description  
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.
Start Date  
02/01/2016
IRB Number  
01-16-25B
Principal Investigator  
Polk, Christopher
Contact Name  
Lisa

For More Information, Contact   Lisa  Engel
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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