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A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium

NCT01242579 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2011-09-09

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc gel and determine whether it is safe for daily use by healthy women in the United Kingdom

Conditions

  • HIV Infections

Interventions

DRUG

Maraviroc/Dapivirine Gel

Vaginal gel containing 2.5g - Maraviroc 0.1%, Dapivirine 0.05%

DRUG

Dapivirine Vaginal Gel

Dapivirine vaginal gel containing 2.5g

DRUG

Maraviroc Vaginal Gel

Maraviroc vaginal gel containing 2.5g

DRUG

Matching Placebo Gel

Matching placebo gel containing 2.5g

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

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
2011-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

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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 NCT01242579 on ClinicalTrials.gov