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

NCT ID: NCT00309205

Last Updated: 2009-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31

Brief Summary

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.

Conditions

HIV Infections; HIV-1

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 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.

• 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

Responsible Party

International Partnership for Microbicides

Principal Investigators

Zeda Rosenberg, ScD

Role: STUDY_DIRECTOR

Beijing Immupeutics Medicine Technology Limited

Locations

SGS Biopharma - Research Unit Stuivenberg

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

IPM005B

Identifier Type: -

Identifier Source: org_study_id