CHARM-03 was an open-label, crossover, randomized Phase I study that evaluated the safety, acceptability, pharmacokinetics and pharmacodynamics of maraviroc gel following rectal and vaginal use, compared to oral maraviroc. All participants received daily oral maraviroc for eight days, daily single-dose rectally administered maraviroc gel for eight days. Female participants additionally received daily single-dose vaginally administered maraviroc gel for eight days. Participants were randomized to different product sequences.
The study was conducted by the Combination HIV Antiretroviral Rectal Microbicide (CHARM) program based at the University of Pittsburgh, and sponsored by IPM in conjunction with NIAID.
- ClinicalTrials ID: NCT02346084
Publications, presentations or other scientific data
- McGowan et al. Safety, pharmacokinetics, and pharmacodynamics of oral and topical maraviroc [poster presentation]. CROI 2018. See abstract.