Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of a 90-day intravaginal ring (IVR) containing tenofovir (TFV).

Timeline

Start

2019-01-02

Primary completion

2019-09-25

Completion

2019-09-25

Publications

• Results Liu AY, Gundacker H, Richardson B, Chen BA, Hoesley C, van der Straten A, Brown A, Beamer M, Robinson J, Jacobson CE, Scheckter R, Bunge K, Schwartz J, Thurman A, Piper JM, Marzinke MA; MTN-038 Protocol Team for the Microbicide Trials Network. Phase 1 randomized pharmacokinetic and safety study of a 90-day tenofovir vaginal ring in the United States. J Int AIDS Soc. 2024 Mar;27(3):e26223. doi: 10.1002/jia2.26223.
• Hawley I, Song M, Scheckter R, McClure T, Piper J, Chen BA, Hoesley C, Liu AY, van der Straten A. Users' Preferred Characteristics of Vaginal Rings for HIV Prevention: A Qualitative Analysis of Two Phase I Trials. AIDS Res Hum Retroviruses. 2022 Apr;38(4):313-326. doi: 10.1089/AID.2021.0077. Epub 2022 Feb 11.

Drugs

Indications