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A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring

NCT01144676 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2010-10-06

No results posted yet for this study

Summary

The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and to assess the safety as compared to placebo vaginal rings in 48 healthy, HIV-negative, sexually active women.

Conditions

  • HIV Infections

Interventions

DRUG

dapivirine

25mg dapivirine per ring. The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days.

DRUG

placebo

The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days.

DRUG

dapivirine

25mg dapivirine per ring. The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours.

DRUG

placebo

The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours.

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Annelene 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
2010-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Belgium

Study Locations

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Entities

Drugs

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 NCT01144676 on ClinicalTrials.gov