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

International Partnership for Microbicides, Inc.13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

HIV Infections

Interventions

dapivirine (TMC120) vaginal ringDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Drug Research Unit Gent

Ghent, Belgium

Outcomes

Primary Outcomes

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).

Data from ClinicalTrials.gov

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