MATRIX-004

Title: Phase I Evaluation of the Impact of Vaginal Sexual Activity on the Pharmacokinetics of Tenofovir Alafenamide and Elvitegravir Vaginal Insert

Brief Description: This Phase I randomized study will enroll approximately 32 healthy, non-pregnant, low risk, HIV-uninfected couples, with approximately 16 couples each at two sites in the United States. The study will evaluate the impact of condomless intercourse (coitus) on pharmacokinetics (PK), pharmacodynamics (PD), safety and acceptability of TAF/EVG vaginal insert when inserted before or after coitus. Participants will be randomized 1:1 to insert vaginal insert before or after coitus. Female participants will also be randomized 1:1 to have a clinic visit, including cervicovaginal biopsies 24 or 72 hours after insertion of vaginal insert.

Protocol Co-Chairs: Leila E. Mansoor, B.Pharm, PhD; Kent Melchiors, MD

Study Sites: Virginia Health Sciences (VHS) in the United States; and Centre for the AIDS Programme of Research in South Africa (CAPRISA) eThekwini in South Africa

Email Groups: MATRIX-004 Protocol Team; MATRIX-004 Management Team