MATRIX-005

Title: Phase 1 first-in-human (FIH) randomized, double-blind placebo-controlled pharmacokinetic and tolerability trial of a dual-purpose intravaginal ring delivering a non-antiretroviral HIV preventative medicine and a non-hormonal contraceptive over 28-days

Brief Description: This Phase I randomized, double-blind, placebo-controlled, ascending dose range finding study will enroll approximately 81 HIV seronegative adult (18-45 years old) persons assigned female sex at birth who are sexual abstinent and at low risk of acquiring HIV infection, with approximately 27 participants at each of 3 sites from the United States, South Africa, Kenya, and/or Zimbabwe. The FIH study of the OneRing will evaluate its tolerability, pharmacokinetics (PK), safety and acceptability when used continuously for 28 days to deliver a broadly antiviral peptide (OCIS-346.232) or a non-hormonal contraceptive (TDI-11155). Participants will be randomized to 1 of 7 study arms: placebo OneRing; low, mid, or high dose TDI-11155 OneRing; low, mid, or high dose OCIS-346-232 OneRing.

Protocol Co-Chairs: TBD

Study Sites: TBD

Email Groups: MATRIX-005 Protocol Development Team