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Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring

NCT02920827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-09-08

No results posted yet for this study

Summary

The proposed study is a single center, double-blind placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.

Conditions

  • HIV Infections

Interventions

COMBINATION_PRODUCT

Dapivirine Vaginal Ring

A platinum-catalysed silicone elastomer matrix vaginal ring containing 25mg of dapivirine used over 28 days

COMBINATION_PRODUCT

Placebo vaginal ring

Placebo vaginal ring containing no dapivirine

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Annalene Nel, PhD · 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
2009-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Belgium

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 NCT02920827 on ClinicalTrials.gov