학술논문
Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women.
Document Type
article
Author
Bunge, Katherine E; Levy, Lisa; Szydlo, Daniel W; Zhang, Jingyang; Gaur, Aditya H; Reirden, Daniel; Mayer, Kenneth H; Futterman, Donna; Hoesley, Craig; Hillier, Sharon L; Marzinke, Mark A; Hendrix, Craig W; Gorbach, Pamina M; Wilson, Craig M; Soto-Torres, Lydia; Kapogiannis, Bill; Nel, Annalene; Squires, Kathleen E; MTN-023/IPM 030 Study Team
Source
Journal of acquired immune deficiency syndromes (1999). 83(2)
Subject
Language
Abstract
BackgroundYoung women aged 15-24 years are disproportionately affected by the HIV epidemic. Two phase III trials of a vaginal ring containing 25-mg dapivirine demonstrated HIV-1 risk reduction in adult women older than 21 years but not in those aged 18-21 years. Lack of protection was correlated with low adherence.MethodsIn this phase-IIa, randomized, double-blind, placebo-controlled, US, multicenter trial of the dapivirine ring in sexually active females, aged 15-17 years, participants were randomized 3:1 to a dapivirine or placebo ring to be inserted monthly for 6 months (NCT02028338). Primary safety end points included grade 2 product related adverse events and any grade 3 and higher adverse events. Adherence to ring use was assessed by plasma dapivirine concentrations, residual levels in used rings, and self-report. A plasma dapivirine concentration of >95 pg/mL was used to define short-term adherence; a residual ring level of