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

International Partnership for Microbicides (IPM)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: dapivirine (TMC120) vaginal gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00304642

IPM004

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.