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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: placebo vaginal ring; Drug: TMC120 (dapivirine) vaginal ring

• Registration Number: NCT00700284
• Lead Sponsor: International Partnership for Microbicides, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-31
• Last Update Posted: 2009-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Female, 18-50 years, inclusive
• Willing and able to provide written informed consent
• HIV-uninfected and otherwise healthy
• Willing to abstain from sexual activity and use of vaginal products while participating in the trial
• Currently using oral contraceptives for pregnancy prevention
• Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial

Exclusion Criteria

• History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
• History of allergy to TMC120 or to the constituents of the vaginal ring.
• History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
• History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
• History of genital tract surgery within the last month
• Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
• Currently or within one month of participating in any other clinical research trial
• Current (during screening) diagnosis of any genital infection
• Current vulvar of vaginal symptoms
• Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	placebo vaginal ring	-
B	TMC120 (dapivirine) vaginal ring	-

Primary Outcome Measures

Name	Time	Method
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)	7 days
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma	7 days

Trial Locations

Locations (1)

Drug Research Unit, UZ Gent; 🇧🇪 Gent, Belgium