drugset

drugset / Trial / NCT02028338

Study of Dapivirine Vaginal Ring (VR) in Adolescents

NCT02028338 ↗

Phase 2 Completed 96 enrolled International Partnership for Microbicides, Inc. Microbicide Trials Network · collab National Institutes of Health (NIH) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.

Timeline

Start: 2014-06-27
Primary completion: 2016-07-05
Completion: 2018-06-08

Publications

Bunge KE, Levy L, Szydlo DW, Zhang J, Gaur AH, Reirden D, Mayer KH, Futterman D, Hoesley C, Hillier SL, Marzinke MA, Hendrix CW, Gorbach PM, Wilson CM, Soto-Torres L, Kapogiannis B, Nel A, Squires KE; MTN-023/IPM 030 Study Team. Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women. J Acquir Immune Defic Syndr. 2020 Feb 1;83(2):135-139. doi: 10.1097/QAI.0000000000002244.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dapivirine	Small molecule	25 mg	Other

Indications