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

HIV Infections Clinical Trial

Official title:

A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309205
• Other study ID #: IPM005B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 30, 2006
• Last updated: August 31, 2009
• Start date: December 2005

Study information

• Verified date: August 2009
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Public Service Health, Food Chain and EnvironmentEurope: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV-1

Intervention

Drug:
• dapivirine (TMC120) vaginal gel

Locations

Country	Name	City	State
Belgium	SGS Biopharma - Research Unit Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and systemic safety and tolerability.