At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
PC-1005 geldrug
Likely dose
PC-1005 gel 4 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 24, 2018·Updated Apr 14, 2023
In Brief
A Phase 1 clinical trial evaluating PC-1005 gel for HIV Infections. Completed, enrolled 13 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartJun 2018
Primary CompletionApr 2019
TodayJul 2026
First PostedJan 24, 2018
Enrollment StartJun 19, 2018
Primary CompletionApr 19, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.4 years ago
Interventions
PC-1005 geldrug
PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL, 16 mL, and 32 mL doses administered rectally.