Marla J Keller, Pedro M Mesquita, Mark A Marzinke, Ryan Teller, Lilia Espinoza, Jessica M Atrio, Yungtai Lo, Bruce Frank, Sujatha Srinivasan, David N Fredricks, Lorna Rabe, Peter L Anderson, Craig W Hendrix, Patrick F Kiser, Betsy C Herold
BACKGROUND: Tenofovir disoproxil fumarate (TDF), a prodrug of tenofovir (TFV), may be ideal for topical HIV preexposure prophylaxis because it has higher tissue and cell permeability than TFV; is not adversely impacted by seminal proteins; and its active metabolite, TFV-diphosphate (TFV-DP), has a long intracellular half-life. We engineered a TDF eluting polyurethane reservoir intravaginal ring (IVR) to provide near constant mucosal antiretroviral concentrations. METHODS: A first-in-human randomized placebo-controlled trial was conducted to assess the safety and pharmacokinetics of the TDF IVR in healthy, sexually abstinent women (15 TDF and 15 placebo)...
March 13, 2016: AIDS