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

International Partnership for Microbicides (IPM)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: dapivirine (TMC120) vaginal ring

Study type

Interventional

Funder types

Industry

Identifiers

NCT00332995

IPM008, TMC120-C131

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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