Carolinas HealthCare System

Research and Clinical Trials

Title   Gilead 0110
Brief Description   The purpose of this study is to see if the combination pill FTC/RPV/TDF is safe and effective in reducing levels of HIV-1 in the blood of subjects who are treatment-naïve (those who have not received any antiretroviral medication).The safety and effectiveness of FTC/RPV/TDF will be compared with that of Atripla®, a combination medication containing efavirenz, FTC, and TDF. Atripla® has been approved by the FDA for the treatment of HIV. An approved dose of Atripla® is being used in this study.
Who may be Eligible  

Subjects with no prior antiretroviral therapy experience for any length of time excluding pre exposure prophylaxis (PrEP) are eligible to participate in this study. Subjects who meet any of the following criteria will not be eligible for the study:
  1. any new AIDS-defining condition diagnosed 30 days prior to screening,
  2. any female who has a positive serum pregnancy test or is breastfeeding,
  3. any proven or suspected hepatitis in the 30 days prior to screening,
  4. any current alcohol or substance abuse that would interfere with compliance,
  5. any history of malignancy in the past 5 years,
  6. any active infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline,
  7. any need to initiate drug therapy that may be contraindicated with study drugs,
  8. any subjects with known allergies to study drugs, any participation in other clinical trials without prior approval from the sponsor,
  9. any treatment with immunosuppressant therapies or chemotherapuetic agents within 3 months of study screening,
  10. any history of liver disease,
  11. and any clinical condition which in the opinion of the Investigator would make the subject unsuitable for the study
Specialty/Disorder   HIV
IRB Number   CHS1-11-255
Principal Investigator   Johnson, Marc
For More Information, Contact   Jessica  A.  Kearney-Bryan , RN
Phone:  (704) 355-0244  Fax:  (704) 446-7641 
Email:  Jessica.kearney-bryan@carolinashealthcare.org
Address:  3rd Floor
Myers Park Clinic
1350 South Kings Drive
Charlotte, NC 28207
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