Microbicide Trials Network

MTN-013/IPM 026

Details

Protocol Title: 
Phase 1 Safety and Pharmacokinetics of Dapivirine/Maraviroc Intravaginal Ring
DAIDS Protocol ID: 
11772
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Beatrice Chen (Protocol Chair)
Lori Panther (Protocol Co-Chair)

Description

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.

Other Study Info

Funding Agencies:

Division of AIDS (DAIDS)/National Institute of Allergy and Infectious Diseases (NIAID)/National Institute of Mental Health (NIMH)/National Institutes of Health (NIH)

IND Sponsor:

International Partnership for Microbicides (IPM)

Study Design:

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