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

NCT00303576 | Completed Phase 1

• 1 other identifier: IPM003
• Study Type: interventional
• Target: 112
• Locations: 3 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Local and systemic safety and tolerability.

Interventions

dapivirine (TMC120) vaginal gel DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (4)

Projet Ubuzima

Kigali, Rwanda

Location

Reproductive Health Research Unit - Sheshisani IPM Clinic

Yeoville, Johannesburg, South Africa

Location

Farmovs-Parexel

Bloemfontein, South Africa

Location

Kilimanjaro Reproductive Health Program

Moshi, Tanzania

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Dapivirine; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Zeda Rosenberg, ScD

  Beijing Immupeutics Medicine Technology Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: October 1, 2005
• Study Completion: July 1, 2006
• Last Updated: July 31, 2006

Record last verified: 2006-07

Locations

TA (1); RW (1); ZA (2)