FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir.
Katherine E BungeCharlene S DezzuttiCraig W HendrixMark A MarzinkeHans M L SpiegelBernard J MonclaJill L SchwartzLeslie A MeynNicola Richardson-HarmanLisa C RohanSharon L HillierPublished in: Journal of the International AIDS Society (2019)
Films were safe and well tolerated. Furthermore, films delivered TFV to mucosal tissues at concentrations similar to gel and were sufficient to block HIV infection of genital tissue ex vivo.