Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring

Summary

This prospective, randomized, single-blinded, placebo controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 14 consecutive days. The primary objective is to assess the safety of TDF vaginal rings when used continuously for 14 days by healthy, HIV-uninfected, sexually abstinent women, as compared with a placebo vaginal ring.

Timeline

Start

2013-11-19

Primary completion

2014-11-06

Completion

2014-11-06

Publications

• Background Smith JM, Rastogi R, Teller RS, Srinivasan P, Mesquita PM, Nagaraja U, McNicholl JM, Hendry RM, Dinh CT, Martin A, Herold BC, Kiser PF. Intravaginal ring eluting tenofovir disoproxil fumarate completely protects macaques from multiple vaginal simian-HIV challenges. Proc Natl Acad Sci U S A. 2013 Oct 1;110(40):16145-50. doi: 10.1073/pnas.1311355110. Epub 2013 Sep 16.
• Background Mesquita PM, Rastogi R, Segarra TJ, Teller RS, Torres NM, Huber AM, Kiser PF, Herold BC. Intravaginal ring delivery of tenofovir disoproxil fumarate for prevention of HIV and herpes simplex virus infection. J Antimicrob Chemother. 2012 Jul;67(7):1730-8. doi: 10.1093/jac/dks097. Epub 2012 Mar 30.

Drugs

Indications