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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304642
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : June 2, 2006
Information provided by:
International Partnership for Microbicides, Inc.

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: dapivirine (TMC120) vaginal gel Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00304642

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South Africa
Bloemfontein, South Africa
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
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Study Director: Zeda Rosenberg, ScD IPM
Layout table for additonal information Identifier: NCT00304642    
Other Study ID Numbers: IPM004
First Posted: March 20, 2006    Key Record Dates
Last Update Posted: June 2, 2006
Last Verified: June 2006
Keywords provided by International Partnership for Microbicides, Inc.:
HIV Seronegativity
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents