MTN-044

MTN-044/IPM 053/CCN019 is a single-site, randomized (1:1), open-label Phase 1 trial. The study will assess the pharmacokinetics and safety of one silicone elastomer vaginal matrix rings containing 200 mg of dapivirine and 320 mg of levonorgestrel. The MTN-044/IPM 053/CCN019 study population consists of healthy, HIV-uninfected, non-pregnant women between 18-45 years of age. The participants will use the vaginal ring either continuously or cyclically (worn for 28 days and taken out for 2 days) for approximately 90 days, and will be followed up for a total duration of approximately 26 weeks. The primary focus of MTN-044/IPM 053/CCN019 is the collection of pharmacokinetic and safety data on the vaginal ring containing a combination of dapivirine and levonorgestrel, formulated with higher dapivirine dose strengths than previously evaluated in Phase 3 trials. Furthermore, MTN-044/IPM 053/CCN019 will assess the vaginal bleeding patterns associated with using the DPV-LNG VR either continuously or cyclically for approximately 90 days. This study will also investigate the acceptability of and adherence to this biomedical HIV prevention-plus-contraception method, and will evaluate the vaginal microenvironment (microflora and biomarkers) and the HIV inhibitory activity in cervical tissue during approximately 90 days of continuous or cyclic study product use. MTN-044/IPM 053/CCN019 is the first study to assess local and systemic PK, safety and tolerability of the DPV-LNG VR when used by women continuously versus cyclically (worn for approximately 28 days and taken out for 2 days) for approximately 90 days.

Protocol Chair(s)
Achilles, Sharon (Protocol Chair)
Chen, Beatrice (Protocol Co-Chair)
Protocol Title
A Randomized, Phase 1, Open-Label Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety and Bleeding Patterns Associated with 90-Day Use of Matrix Vaginal Rings Containing 200 mg Dapivirine and 320 mg Levonorgestrel
DAIDS Protocol ID
38520
Status
Enrolling
Formulation
Vaginal Ring
Drug
Dapivirine
Levonorgestrel
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
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

Source URL: https://mtnstopshiv.org/research/studies/mtn-044