Microbicide Trials Network

MTN-030/IPM 041

Details

Protocol Title: 
A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel Vaginal Rings
DAIDS Protocol ID: 
12037
Status: 
Closed to Follow Up

Protocol Chair(s)

Sharon Achilles (Protocol Chair)
Beatrice Chen (Protocol Co-Chair)

Description

MTN-030/IPM 041 is a Phase 1, randomized, double blind, multi-site trial. MTN-030/IPM 041 is the first in-human study of a vaginal ring containing a combination of dapivirine and levonorgestrel. The study will assess the safety and pharmacokinetics (PK) of a silicone elastomer vaginal matrix ring containing 200 mg of dapivirine alone or 200 mg of dapivirine and either 32 mg or 320 mg of levonorgestrel. Approximately 36 healthy, HIV-uninfected, non-pregnant women between 18-45 years of age will be on study product for approximately 14 consecutive days.  Accrual is expected to take 8-10 months. The primary focus of MTN-030/IPM 041 is the collection of local and systemic pharmacokinetic data as well as to collect safety information on the vaginal rings. MTN-030/IPM 041 will also examine what effects, if any, the study product has on participants’ bleeding patterns.  Furthermore, MTN-030/IPM 041 will investigate the acceptability of and adherence to this biomedical HIV prevention-plus-contraception method and explore changes in vaginal microflora and biomarkers over 14 days of product use.

Other Study Info

Sponsor:

Division of AIDS, US National Institute of Allergy and Infectious Diseases 

US Eunice Kennedy Shriver National Institute of Child Health and Human Development 

US National Institute of Mental Health 

US National Institutes of Health 

Co-Sponsor:

IPM 

Study Design:

Phase 1, multi-site, three-arm, randomized (1:1:1), double-blinded trial