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MTN-013/IPM 026 was a Phase 1 safety and PK study of approximately 48 healthy, HIV-uninfected, sexually abstinent, 18-40 year old women. Participants were randomized to one of four study regimens (VR containing either 25 mg dapivirine, or 100 mg maraviroc, or 25 mg dapivirine + 100 mg maraviroc or placebo) in a 1:1:1:1 ratio. The VR was worn for approximately 28 consecutive days. Safety assessments were conducted with special consideration for monitoring systemic toxicity and intensive PK assessments were conducted at multiple time points. 

MTN-013/ IPM 026 was the first-in-human clinical trial that evaluated a VR containing maraviroc alone or in combination (dapivirine/maraviroc). The design of MTN-013/IPM 026 allowed safety comparisons of each product to a placebo and provided data regarding the absorption and distribution of the drug(s) administered. Primary study results were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) held on March 3-6, 2014, in Boston, MA.  The primary results manuscript was published in JAIDS in November 2015.

Protocol Chair(s)
Chen, Beatrice (Protocol Chair)
Panther, Lori (Protocol Co-Chair)
Protocol Title
Phase 1 Safety and Pharmacokinetics of Dapivirine/Maraviroc Intravaginal Ring
DAIDS Protocol ID
11772
Status
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Maraviroc
Placebo
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Pharmacokinetics
Pharmacodynamic
Safety
Study Phase
Phase I  
Countries
United States
Population
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS (DAIDS)/National Institute of Allergy and Infectious Diseases (NIAID)/National Institute of Mental Health (NIMH)/National Institutes of Health (NIH)
Sponsor(s)
International Partnership for Microbicides (IPM)
Other Study Info

Multi-site, double-blinded, four-arm, randomized, placebo-controlled trial