NCT02033109

Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use

A Phase 1, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Acceptability of PC-1005 Microbicide Gel Formulation in HIV-seronegative Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Population Council · Academic / Other
• Sex: Female
• Age: 19 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the prevention of HIV infection in women. This is the first in-human of PC-1005 (MIV-150/zinc acetate in a carrageenan gel), the first study in which females will be exposed to MIV-150, the first time MIV-150 will be administered topically, and the first time MIV-150 will be administered intravaginally.

Detailed description

This study will begin with a safety run-in, which is an open label, single-arm safety run-in with 5 women receiving PC-1005 once daily for 3 consecutive days. Safety and pharmacokinetics will take place after each dose. the participants from the run-in will not be eligible for the main study. The main study participants will be randomized 4:1 to the study gels: 24 randomized to PC-1005 (active) and 6 randomized to HEC gel (placebo). The study product will be applied vaginally once daily for 14 days with clinical and laboratory assessments at baseline (enrollment) and after the 1st, 2nd, 8th, 9th, and 14th doses, and a safety follow-up visit 7 days after the 14th dose. Participants in the run-in and main study will be requested to be sexually abstinent starting immediately after the Screening Visit until study exit.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	PC-1005	Intravaginal use
DRUG	HEC gel

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2014-01-10
• Last updated: 2017-08-15

Locations

1 site across 1 country: United States