MATRIX-001

Title: A Phase I Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Pharmacokinetics, and Modeled Pharmacodynamics of a Vaginal Insert Containing Tenofovir Alafenamide and Elvitegravir

Brief Description: This study will enroll approximately 60 healthy, non-pregnant, HIV-uninfected women aged 18-50 years who are not at risk for pregnancy and are at low risk for sexually transmitted infections at three clinical sites in the US, South Africa, and Kenya. MATRIX-001 will examine the safety, pharmacokinetics, modeled pharmacodynamics, disintegration, and acceptability of human-centered designed inserts containing the combination of tenofovir alafenamide (TAF) and elvitegravir (EVG). Participants will be randomized (1:1) to apply either a placebo or TAF/EVG insert vaginally once daily for 3 consecutive days and every other day (QOD) for 14 days.

Study Sites: Eastern Virginia Medical School (EVMS) CRS; Centre for the AIDS Programme of Research in South Africa (CAPRISA) eThekwini CRS; and Kenyan Medical Research Institute (KEMRI) Thika CRS

Protocol Co-Chairs: Leila E Mansoor, B.Pharm, PhD (CAPRISA); Nelly R Mugo, MBChB, MMed, MPH (KEMRI)

Email Groups: MATRIX-001 Clinical Management Team; MATRIX-001 Management Team; MATRIX-001 Protocol Safety Review Team; MATRIX-001 Protocol Team; MATRIX-001 Safety Physician