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A Safety Study of Dapivirine Vaginal Ring in Africa

NCT01071174 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2011-08-02

No results posted yet for this study

Summary

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

Conditions

  • HIV Infections

Interventions

OTHER

Dapivirine

Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)

OTHER

Placebo

Vaginal Ring containing no drug substance

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr Annalene Nel · Beijing Immupeutics Medicine Technology Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-05-31
Completion
2011-07-31

Countries

  • Kenya
  • Malawi
  • South Africa
  • Tanzania

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 NCT01071174 on ClinicalTrials.gov