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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.

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