A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium

International Partnership for Microbicides (IPM)

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV-1

HIV Infections

Treatments

Drug: dapivirine (TMC120) vaginal gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00309205

IPM005B

Details and patient eligibility

About

Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

HIV-negative
Willing to participate and sign an informed consent form
Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
Willing to use two forms of contraception during the study
Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

Exclusion criteria

Currently pregnant or breast-feeding
Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.