A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel

NCT00304642 | Completed Phase 1

• 1 other identifier: IPM004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.

Conditions

HIV Infections

Keywords

HIV-1; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.

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 and informed consent form.
• Willing to be tested for HIV and to use an experimental vaginal gel.
• Willing to use a reliable form of contraception during the study.
• Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study.
• Normal cervical assessment.
• Willing to abstain from using any vaginal product (other than the study product).
• Willing to be sexually abstinent from Day 1 until completion of study product use on Day 10.

You may not qualify if:

• Currently pregnant or breast-feeding.
• Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix.
• Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test.
• Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment.
• Current use of injection drugs.

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (1)

Farmovs-Parexel

Bloemfontein, South Africa

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 16, 2006
• First Posted: March 20, 2006
• Study Start: November 1, 2005
• Last Updated: June 2, 2006

Record last verified: 2006-06

Locations

ZA (1)