Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse.

Timeline

Start

2018-06-19

Primary completion

2019-04-19

Completion

2019-04-19

Publications

• Ho K, Hoesley C, Anderson PL, Fernandez-Romero JA, Friedland BA, Kelly CW, Jiao Y, Edick S, Brand R, Kunjara Na Ayudhya RP, Zyhowski A, Hartman DJ, Reddy NB, Al-Khouja A, Piper J, Bauermeister JA, Teleshova N, Melo C, Cornejal N, Barnable P, Singh D, Scheckter R, McClure T, Hillier SL, Hendrix CW; MTN-037 Study Team. Phase I Dose Volume Escalation of Rectally Administered PC-1005 to Assess Safety, Pharmacokinetics, and Antiviral Pharmacodynamics as a Multipurpose Prevention Technology (MTN-037). J Acquir Immune Defic Syndr. 2024 Dec 1;97(4):379-386. doi: 10.1097/QAI.0000000000003506.

Drugs

Indications