This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and
emtricitabine (components of Truvada) concentrations within genital tract of male and females
after a single dose of Truvada®. Concentrations of the active drug will be measured in blood
(women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal fluid and
rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours (2 days), 5
days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy days, at
least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for HIV
infectivity.
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Gilead Sciences
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir