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A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

NCT01337570 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-06-11

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled Phase III study to assess the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.

Conditions

  • HIV Infections

Interventions

OTHER

Dapivirine

Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months

OTHER

Placebo

Vaginal Ring containing no drug substance

DRUG

Dapivirine

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Annalene Nel · Beijing Immupeutics Medicine Technology Limited

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
2011-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Malawi
  • Rwanda
  • South Africa
  • Zimbabwe

Study Locations

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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 NCT01337570 on ClinicalTrials.gov