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

A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00304642

Enrollment

Registered

2006-03-20

Start date

2005-11-30

Completion date

Unknown

Last updated

2006-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1, HIV Seronegativity

Brief summary

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.

Interventions

DRUGdapivirine (TMC120) vaginal gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.	—

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026