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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
35
University of Alabama at Birmingham
Birmingham, Alabama, United States
Safety: adverse events, serious adverse events, physical exams, and clinical laboratory parameters
* Number and percent of participants with treatment emergent adverse events and adverse events, and medical significance of adverse events and serious adverse events * Number, percent and medical significance of abnormalities in physical exams, pelvic exams, and biopsies once product has been administered * Number, percent and medical significance of abnormalities in clinical laboratory parameters once product has been administered
Time frame: 5 weeks for safety run-in study; 7 weeks for main study
Assessment of acceptability and adherence of PC-1005 use in seronegative women (main study only)
Questionnaire, self-report, and applicators returned empty
Time frame: 14 days
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