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

HIV Infections Clinical Trial

Official title:

A Phase I/II Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303576
• Other study ID #: IPM003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 15, 2006
• Last updated: July 28, 2006
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: July 2006
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilTanzania: Food and Drug AuthorityRwanda: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 2006
• 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

• 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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• dapivirine (TMC120) vaginal gel

Locations

Country	Name	City	State
Rwanda	Projet Ubuzima	Kigali
South Africa	Farmovs-Parexel	Bloemfontein
South Africa	Reproductive Health Research Unit - Sheshisani IPM Clinic	Yeoville	Johannesburg
Tanzania	Kilimanjaro Reproductive Health Program	Moshi

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Countries where clinical trial is conducted

Rwanda,  South Africa,  Tanzania, 

Outcome

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