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Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

NCT00700284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-09-01

No results posted yet for this study

Summary

The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.

Conditions

  • HIV Infections

Interventions

DRUG

placebo vaginal ring

vaginal ring containing no TMC120 (dapivirine)

DRUG

TMC120 (dapivirine) vaginal ring

vaginal ring containing 120 mg TMC120 (dapivirine)

Sponsors & Collaborators

  • Tibotec Pharmaceutical Limited

    collaborator INDUSTRY

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr Luc Van Bortel · Drug Research Unit, UZ Gent

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2005-01-31
Completion
2005-01-31

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 NCT00700284 on ClinicalTrials.gov