Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring (TDF IVR-002)
Status:
Terminated
Trial end date:
2017-10-17
Target enrollment:
Participant gender:
Summary
This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will
examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate
(TDF) vaginal ring when used continuously for 84 consecutive days by sexually active women.
The primary objective is to assess the safety of TDF vaginal rings when used continuously for
84 days by healthy, HIV-uninfected, sexually active women, as compared with a placebo vaginal
ring.
Phase:
Phase 1
Details
Lead Sponsor:
Albert Einstein College of Medicine of Yeshiva University Marla Keller
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)