MTN-037 is a Phase 1, open label, sequential dose/volume escalation study designed to evaluate the safety and pharmacokinetics of PC-1005 (MIV-150/zinc acetate/carrageenan gel) when administered rectally. Approximately 12 healthy, HIV-uninfected men and women (cis or transgender) who are 18 years of age or older and who have a history of consensual receptive anal intercourse (RAI) will be enrolled in MTN-037. PC-1005 was designed to be a dual compartment gel (vaginal or rectal use), with potential activity against HIV-1, herpes simplex virus type 2 (HSV-2), and human papilloma virus (HPV).
Study product will be rectally administered by clinic staff. Each participant will receive a total of three doses of PC-1005 (1st dose = 4mL, 2nd dose = 16mL, and 3rd dose = 32mL), with a 2-6-week washout period between each dose. Study endpoint assessments will be performed within 24-48 hours of each of the three product applications. It is hypothesized that PC-1005 gel will be safe when applied to the rectum and well-tolerated among healthy men and women (cis or transgender). It is anticipated that this study will take approximately 6-8 months to enroll the target sample size, and that total study duration for participants will be approximately 3-5 months.
MTN-037 is the first study to assess the safety and PK of PC-1005 gel applied rectally.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Phase 1, open label, sequential dose/volume escalation trial