MTN-030/IPM 041

MTN-030/IPM 041 was a multi-site, randomized, double blind Phase 1 trial. The study assessed pharmacokinetics and safety of two silicone elastomer vaginal matrix rings containing either 200 mg of dapivirine alone or 200 mg of dapivirine and 320 mg of levonorgestrel. The MTN-030/IPM 041 study population consisted of healthy, HIV-uninfected, non-pregnant women between 18-45 years of age. 24 participants were randomized (1:1) to use one of the two vaginal rings for a period of approximately 14 days and were followed up for a total duration of approximately 16 days. The primary objectives of MTN-030/IPM 041 was to collect pharmacokinetic and safety data on rings containing either dapivirine alone or a combination of dapivirine and levonorgestrel, formulated with higher dapivirine dose strengths than previously evaluated in Phase 3 trials. The effects, if any, the study product had on vaginal bleeding patterns was also examined. MTN-030/IPM 041 assessed the acceptability of and adherence to this biomedical HIV prevention-plus-contraception method and evaluated the vaginal microenvironment (microflora and biomarkers) during 14 days of continuous study product use.

MTN-030/IPM 041 was the first in human study of a vaginal ring containing a combination of dapivirine and levonorgestrel. The study completed follow-up on August 18, 2017. Primary results were presented at the HIV Research for Prevention (HIVR4P) conference held on October 22-25, 2018 in Madrid, Spain. The primary manuscript which includes data from both MTN-030 and MTN-044 is currently in development.

Protocol Chair(s)
Achilles, Sharon (Protocol Chair)
Chen, Beatrice (Protocol Co-Chair)
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
Formulation
Vaginal Ring
Drug
Dapivirine
Levonorgestrel
Study Focus/Product Administration
Vaginal
Study Type
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Women (cisgender women, non‐transgender women)
Funder(s)
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
Sponsor(s)
IPM
Other Study Info

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


Source URL: https://mtnstopshiv.org/research/studies/mtn-030ipm-041