Dialysis and HIV study
You are invited to participate in a clinical research study. This study will test an investigational use for the drug called called Genvoya® which uses the medications elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in a fixed dose combination (E/C/F/TAF FDC) for the treatment of HIV-1 infection. An investigational use means that the drug has previously been approved by the US FDA, but has not been approved for this specific use (for example, use in people on chronic hemodialysis).
The purpose of this study is to test the safety, tolerability and effectiveness of E/C/F/TAF FDC (referred to as ‘study drug’) in virologically suppressed HIV-1 infected subjects, who are on chronic hemodialysis because of the end stage renal disease. In order to take part in the study, you will need to switch from your current antiretroviral (ARV) regimen to E/C/F/TAF/FDC. The safety and how well E/C/F/TAF FDC is tolerated will be determined by using physical exams, laboratory tests, and questions asked about any problems you might experience during the study.
If you agree to take part in this study, you will be one of approximately 50 subjects in this study. There will be approximately 4 participants here at UNC – Chapel Hill. The study will take place at about 50 sites in Europe and North America.
You may qualify if you:
- Are at least 18 years of age
- Are on chronic hemodialysis for at least 6 months prior to study start
- Have currently been receiving a stable HIV treatment regimen for at least 6 months
- Have an undetectable viral load (less than 50 copies/mL) for at least 6 months
- Have not documented history of resistance or switching treatment due to resistance of EVG (elvitegravir), FTC (emtricitabine), 3TC (lamiduvine) or TFV (tenofovir)
Those who qualify will take the study medication for at least 48 weeks and will receive all study-required labs and procedures at no cost. All subjects will receive the investigational medication during study participation.
Speak with your doctor about taking part in this important study.
For more details, contact Donna Pittard, RN (Research Study Coordinator at UNC) at 919-843-6512