Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults

Summary

The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of maraviroc gel following rectal and vaginal administration. The study also includes oral exposure to maraviroc.

Timeline

Start

2015-01

Primary completion

2015-12

Completion

2016-03

Publications

• McGowan IM, Chawki S, Hendrix CW, Anton PA, Marzinke MA, Brand RM, Engstrom JC, Rohan LC, Abebe KZ, Richardson-Harman N, Siegel A, Reinhart A, Steytler J, Stall R, Spiegel H, Chen B, Achilles SL, Jacobson CE, Khanukova E, Cranston RD. A Randomized, Open-Label, Crossover Phase 1 Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel (the CHARM-03 Study). AIDS Res Hum Retroviruses. 2022 Apr;38(4):269-278. doi: 10.1089/AID.2021.0096. Epub 2021 Sep 14.

Drugs

Indications