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