MTN-037

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A Phase 1 sequential volume escalation trial of PC-1005 administered rectally.

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.

Goals

Primary Objectives:

Safety
- To evaluate the safety of PC-1005 gel formulation (0.002% MIV-150/0.3% zinc acetate [ZA] in 3.0% carrageenan [CG] gel) when applied rectally
Pharmacokinetics
- To characterize the systemic and compartmental pharmacokinetics of MIV-150 following rectal gel application

Secondary Objectives:

Acceptability
- To compare the acceptability of PC-1005 gel formulation across the three doses when administered rectally
Pharmacokinetics
- To characterize the compartmental pharmacokinetics of MIV-150 in vaginal fluid following rectal gel application

Exploratory Objectives:

Biomarkers of Mucosal Safety
- To evaluate the mucosal toxicity of PC-1005 gel formulation when applied rectally
Ex Vivo Antiviral Activity
- To assess the preliminary (ex vivo) antiviral activity of PC-1005 gel formulation after product is applied rectally