A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.