A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel

NCT ID: NCT00303576

Last Updated: 2006-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-07-31

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. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.

Conditions

HIV Infections

Keywords

HIV-1; HIV Seronegativity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

dapivirine (TMC120) vaginal gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Zeda Rosenberg, ScD

Role: STUDY_DIRECTOR

Beijing Immupeutics Medicine Technology Limited

Locations

Projet Ubuzima

Kigali, , Rwanda

Reproductive Health Research Unit - Sheshisani IPM Clinic

Yeoville, Johannesburg, South Africa

Farmovs-Parexel

Bloemfontein, , South Africa

Kilimanjaro Reproductive Health Program

Moshi, , Tanzania

Countries

Rwanda; South Africa; Tanzania

Other Identifiers

IPM003

Identifier Type: -

Identifier Source: org_study_id