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Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women

NCT01617096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2629

Last updated 2022-12-21

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

Dapivirine Vaginal Ring

Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months

COMBINATION_PRODUCT

Placebo Ring

Vaginal ring containing no drug substance

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Jared Baeten, MD, PhD · International Clinical Research Center, Department of Global Health, University of Washington

  • Thesla Palanee, PhD · Wits Reproductive Health and HIV Institute (WRHI), Research Centre

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
2012-07-24
Primary Completion
2015-07-03
Completion
2015-12-31
FDA Drug
Yes

Countries

  • Malawi
  • South Africa
  • Uganda
  • 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 NCT01617096 on ClinicalTrials.gov