Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women

Status Recruiting

Clinical Trial Summary

This study will provide data on the PK profile of dapivirine drug in lactating women who have completed weaning when administered in VR formulation. It evaluates dapivirine levels in both plasma and breast milk and the amount of drug transferred into breast milk during the participant's 14 days of use

Clinical Trial Description

Secondary Endpoints: 1. Safety and Tolerability, 2 Adherence , measured by blood dapivirine levels and residual levels in returned vaginal rings. Exploratory Objectives: Describe changes in vaginal microflora after 14 consecutive days of dapivirine vaginal ring use, and Describe dapivirine anti-HIV activity in breast milk. Exploratory Endpoints: Candidate biomarkers of vaginal microflora and anti-HIV activity in breast milk. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT02658227
Study type	Interventional
Source	International Partnership for Microbicides, Inc.
Contact	Lisa Noguchi, PHD CNM
Phone	202-664-2721
Email	inoguch1@jhu.edu
Status	Recruiting
Phase	Phase 1
Start date	February 2016
Completion date	August 2017

View Details

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