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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Group Type PLACEBO_COMPARATOR

placebo vaginal ring

Intervention Type DRUG

vaginal ring containing no TMC120 (dapivirine)

B

Group Type EXPERIMENTAL

TMC120 (dapivirine) vaginal ring

Intervention Type DRUG

vaginal ring containing 120 mg TMC120 (dapivirine)

Interventions

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placebo vaginal ring

vaginal ring containing no TMC120 (dapivirine)

Intervention Type DRUG

TMC120 (dapivirine) vaginal ring

vaginal ring containing 120 mg TMC120 (dapivirine)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes