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Completed

NCT Number: NCT00304642

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Farmovs-Parexel

Bloemfontein, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

dapivirine (TMC120) vaginal gel

Drug

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.

Sponsors and collaborators

Lead sponsor

International Partnership for Microbicides, Inc.

Industry

Registry information

Official study title

A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.

Important dates

Study start
2005
First posted
Mar 20, 2006
Registry last updated
Jun 2, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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