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NCT02033109 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use
A Phase 1 study of HIV, sponsored by Population Council.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT02033109: Completed Phase 1 study of HIV, sponsored by Population Council.
NCT02033109 is a Phase 1 study of HIV that has completed, run by Population Council. The registered enrollment target is 35 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02033109, a Phase 1 study of HIV, has completed, sponsored by Population Council.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
* 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
Conditions Studied
Interventions
- DRUG PC-1005
- DRUG HEC gel
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT02033109 record still lists
NCT02033109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which PC-1005 is the first listed.
NCT02033109 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT02033109 about?
NCT02033109 is a clinical study titled "Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use". 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...
What is the current status of trial NCT02033109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2014-05. Estimated completion is 2015-06.
What conditions does trial NCT02033109 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT02033109?
The interventions under investigation include: PC-1005 (DRUG), HEC gel (DRUG).
Who is sponsoring clinical trial NCT02033109?
This trial is sponsored by Population Council, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02033109 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02033109's enrollment target sits among peer trials
35 254th of 303 higher than 49 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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