Early Termination of a Phase 1 Randomized Trial of Tenofovir Disoproxil Fumarate Intravaginal Ring Linked to Inflammation

This Phase 1, single-blind, randomized, placebo-controlled trial evaluated the safety, pharmacokinetics, and acceptability of a Tenofovir Disoproxil (TDF) intravaginal ring (IVR) that was used continuously with monthly ring changes for three months. Changes in the vaginal microbiota were characterized using broad-range PCR and sequencing, which was applied to vaginal fluid samples obtained from 5 women in the placebo arm, and 11 women in the TDF arm. No major shifts were noted when we compared the relative abundances of bacterial taxa on day 28 compared to enrollment in either the TDF or placebo arm. The Shannon Diversity Index was also not different between the two groups suggesting that the vaginal microbiota was not impacted by the TDF IVR.