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

NCT02033109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-08-15

No results posted yet for this 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.

Conditions

Interventions

DRUG

PC-1005

Intravaginal use

DRUG

HEC gel

Sponsors & Collaborators

  • Population Council

    lead OTHER

Principal Investigators

  • Craig J Hoesley, MD · University of Alabama at Birmingham

  • George W Creasy, MD · Population Council

  • Barbara Friedland, MPH · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02033109 on ClinicalTrials.gov