A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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dapivirine (TMC120) vaginal gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-negative
* Willing to participate and sign and informed consent form.
* Willing to be tested for HIV and to use an experimental vaginal gel.
* Willing to use a reliable form of contraception during the study.
* Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study.
* Normal cervical assessment.
* Willing to abstain from using any vaginal product (other than the study product).
* Willing to be sexually abstinent from Day 1 until completion of study product use on Day 10.

Exclusion Criteria

* Currently pregnant or breast-feeding.
* Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix.
* Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test.
* Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment.
* Current use of injection drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Zeda Rosenberg, ScD

Role: STUDY_DIRECTOR

Beijing Immupeutics Medicine Technology Limited

Locations

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Farmovs-Parexel

Bloemfontein, , South Africa

Site Status

Countries

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South Africa

Other Identifiers

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IPM004

Identifier Type: -

Identifier Source: org_study_id