IRB 16-2122: Does Sex Hormone Therapy decrease Nucleos(t)ide Reverse Transcriptase Inhibitors (NRTI) Active Metabolite Formation in Mucosal Tissues?

Q: To determine whether sex hormone therapy alters TDF/FTC intracellular pharmacology in the genital and lower gastrointestinal tracts by decreasing concentrations of active metabolites
POP: There will be 12 HIV-infected participants receiving TDF/FTC divided evenly over 3
cohorts. Currently recruiting Cis-gendered HIV positive males, and HIV-negative cis-
gender males on PrEP.
MED: On a background regimen containing TDF/FTC (All Cohorts)
DUR: Between 1-2 months (Screening visit, Sampling visit, and Follow-up)
CALL: Heather Prince, PA-C 919-962-5344

IRB 17-0546: ENLIGHTEN: Establishing Novel Antiretroviral for Hair to Elucidate Nonadherence

Q: To determine if hair can be utilized as an alternative to blood monitoring of antiretroviral adherence.
POP: 36 healthy adults divided into 3 different drug groups. Aged 18-70 years, inclusive, able to maintain a minimum of one centimeter of caput hair during the entire study period, with an intact gastrointestinal system.
MED: Maraviroc, Dolutegravir, Truvada. Single-dose, Multiple doses, Dose-Proportionality Phases. All doses directly observed.
DUR: Screening visit, Phase 1, Phase 2, Phase 3, and Follow-up within 14 days of Phase 3 completion. Each phase consists of 28 days and includes dosing and sampling (blood and hair) visits.
CALL: Heather Prince, PA-C 919-962-5344