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

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 (TMC120 Gel-002) vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00304668
• Other study ID #: IPM005A
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 17, 2006
• Last updated: December 8, 2015

Study information

• Verified date: May 2006
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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 (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• dapivirine (TMC120) vaginal gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Outcome

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