Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States.

ABSTRACT:

Introduction

Vaginal rings are a promising approach to provide a woman-centred, long-acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV-1 infection. Extended duration rings replaced every three months may encourage user adherence, improve health service efficiency and reduce cost overall. We evaluated safety, pharmacokinetics, adherence and acceptability of two three-month rings with different DPV dosages, compared with the monthly DPV ring.

Methods

From December 2017 to October 2018, MTN-036/IPM-047 enrolled 49 HIV-negative participant in Birmingham, Alabama and San Francisco, California into a phase 1, randomized trial comparing two extended duration (three-month)

SUBMITTER: Liu AY 

PROVIDER: S-EPMC8196716 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature