Status:
COMPLETED
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
Lead Sponsor:
International Partnership for Microbicides, Inc.
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel....
Eligibility Criteria
Inclusion
- HIV-negative
- Willing to participate and sign an informed consent
- 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.
- Willing to abstain from using any vaginal product (other than the study product or placebo).
- Willing to be sexually abstinent from randomization until completion of Day 7 evaluations.
Exclusion
- 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 genital ulcer disease or active HSV-2 lesions.
- Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization.
- Symptomatic bacterial vaginosis and unwilling to undergo treatment.
- Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00303576
Start Date
October 1 2005
End Date
July 1 2006
Last Update
July 31 2006
Active Locations (4)
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1
Projet Ubuzima
Kigali, Rwanda
2
Reproductive Health Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg, South Africa
3
Farmovs-Parexel
Bloemfontein, South Africa
4
Kilimanjaro Reproductive Health Program
Moshi, Tanzania