MTN-037

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.

Protocol Chair(s)
Hendrix, Craig (Protocol Chair)
Protocol Title
A Phase 1 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults
DAIDS Protocol ID
35122
Status
Enrolling
Formulation
Gel
Drug
PC‐1005 (MIV‐150/Zinc Acetate/Carrageenan Gel)  
Study Focus/Product Administration
Rectal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender women
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
DAIDS
Other Study Info

Phase 1, open label, sequential dose/volume escalation trial


Source URL: https://mtnstopshiv.org/research/studies/mtn-037