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.


Carolinas HealthCare System

Research and Clinical Trials

Title  
GS-US-366-1160
Brief Description  
HIV treatment experienced study looking at those on a current regimen containing EFV/FTC/TDF FDC (Atripla) to continue treatment, versus switching to FTC/RPV/TAF FDC.
Who may be Eligible  
Adults ages 18 years or older; currently receiving antiretroviral regimen containing EFV/FTC/TDF FDC (Atripla) for =6 consecutive months prior to screening; Plasma HIV-1 RNA levels <50 copies/mL for at least 6 months prior to screening visit and at screening visit; Normal ECG; Normal maintenance lab values; Not pregnant, nursing, or planning to become pregnant during 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 defibrillator or pacemaker; No history of malignancy with 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 any of study agents at any time in past; Serum amylase =5x ULN (subjects with serum amylast >5x ULN will remain eligible if Serum lipase is =5X ULN); Adequate renal function
Specialty/Disorder  
HIV
Start Date  
04/21/2015
IRB Number  
CHS1-15-147
Principal Investigator  
Polk, Christopher
Contact Name  
Lisa

For More Information, Contact   Lisa  A.  Engel
Phone:  (740) 667-5324  Fax:  (704) 331-9266 
Email:  Lisa.engel@carolinashealthcare.org
Address:  4539 Hedgemore Drive, Suite 100
Charlotte, NC 28209
Close