Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332995

Enrollment

Registered

2006-06-02

Start date

2005-07-31

Completion date

2005-08-31

Last updated

2009-09-01

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

Conditions

HIV Infections

Keywords

HIV Seronegativity

Brief summary

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

Interventions

DRUGdapivirine (TMC120) vaginal ring

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

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

Exclusion criteria

* History of allergy to TMC120 or to the constituents of the vaginal ring * 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 study * Current vulvar or vaginal symptoms / abnormalities that could influence the study results * Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption * Current diagnosis of any genital infection * Smoking more than 10 cigarettes / day

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).	—
Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120).	—

Countries

Belgium

Outcome results

None listed

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