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Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring

NCT01363037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-09-10

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.

Conditions

  • HIV Infections

Interventions

DRUG

Dapivirine Vaginal Ring

dosage form: dapivirine vaginal ring dosage:25 mg frequency:continuous use duration:28 days

DRUG

Maraviroc Vaginal Ring

dosage form: maraviroc vaginal ring dosage:100 mg frequency:continuous use duration:28 days

OTHER

Placebo Vaginal Ring

dosage form: placebo vaginal ring dosage:N/A frequency:continuous use duration:28 days

DRUG

Dapivirine-Maraviroc Vaginal Ring

dosage form: combination vaginal ring dosage:25 mg dapivirine + 100 mg maraviroc frequency:continuous use duration:28 days

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Beatrice A Chen, MD, MPH · University of Pittsburgh

  • Lori Panther, MD, MPH · The Fenway Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01363037 on ClinicalTrials.gov