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A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

NCT00469768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-09-01

No results posted yet for this study

Summary

IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

Conditions

  • HIV Infections

Interventions

DRUG

dapivirine reservoir intravaginal ring

a silicone elastomer reservoir ring containing 25mg of dapivirine

DRUG

dapivirine matrix intravaginal ring

a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine

OTHER

placebo intravaginal ring

a silicone elastomer intravaginal ring containing no dapivirine

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Annalene Nel · International Partnership for Microbicides (IPM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Completion
2007-08-31

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 NCT00469768 on ClinicalTrials.gov