HIV Infections
Conditions
Keywords
HIV-1, HIV Seronegativity
Brief summary
Approximately 42 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-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.
Interventions
Sponsors
International Partnership for Microbicides, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local and systemic safety and tolerability. | — |
Outcome results
None listed