MedTrace Logo

Assessing the Safety of Dapivirine Gel and Film Formulations

NCT01548560 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-09-08

No results posted yet for this study

Summary

This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.

Conditions

  • HIV Infections

Interventions

DRUG

Dapivirine Vaginal Film

Dosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses

DRUG

Dapivirine Vaginal Gel

Dosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Katherine Bunge, MD MPH · Magee Womens Hospital, UPitt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT01548560 on ClinicalTrials.gov