RMP-02/MTN-006 was a Phase 1, partially-blinded, placebo-controlled trial designed to evaluate the safety, acceptability, pharmacokinetics and pharmacodynamics of rectal administration of tenofovir 1% vaginally formulated gel and oral tenofovir (TDF) in healthy men and women. This tenofovir gel formulation was originally designed for vaginal use. The primary objective of this trial was to evaluate the systemic safety profile of vaginally formulated tenofovir 1% gel, applied rectally, during a single exposure, followed by once-daily rectal administration for 7 days, as compared to a single oral dose of tenofovir. In addition to acceptability, RMP-02/MTN-006 assessed concentrations of tenofovir in tissue, rectal fluid, intracellular (both peripheral blood mononuclear cells (PBMC)) and mucosal mononuclear cells (MMC), and plasma.
Determining whether the intracellular levels of tenofovir diphosphate concentrations in presumptive mucosal target cells are similar using topical or oral formulations will impact clinical trials and drug development plans for prevention of HIV among populations for whom receptive anal intercourse is a route of HIV exposure. This was a joint project of the MTN and the Integrated Preclinical Clinical Program (IPCP) in Topical Microbicides funded by the Division of AIDS. This study was the first MTN trial to leverage the IPCP in Topical Microbicides through collaboration with the UCLA IPCP on rectal microbicides (Peter Anton, PI). The MTN partnered with the IPCP to provide CORE resources, laboratory support, and CRS support for the study. Preliminary results were reported at annual Conference on Retroviruses and opportunistic Infections (CROI) in held on February 27-March 2, 2011 in Boston, MA.
US National Institutes of Health
Phase 1, randomized, two-site, partially-blinded, placebo controlled study