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Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

NCT01539226 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1959

Last updated 2022-10-19

Study results available
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Summary

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Conditions

  • HIV Infections

Interventions

COMBINATION_PRODUCT

Placebo Vaginal Ring

Dapivirine Vaginal Ring containing 0.0 mg of dapivirine

COMBINATION_PRODUCT

Dapivirine Vaginal Ring, 25 mg

Dapivirine Vaginal Ring containing 25 mg of 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
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-27
Primary Completion
2016-12-13
Completion
2016-12-13

Countries

  • South Africa
  • Uganda

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 NCT01539226 on ClinicalTrials.gov