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Completed

NCT Number: NCT00700284

Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.

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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

Drug Research Unit, UZ Gent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female, 18-50 years, inclusive
  • Willing and able to provide written informed consent
  • HIV-uninfected and otherwise healthy
  • Willing to abstain from sexual activity and use of vaginal products while participating in the trial
  • Currently using oral contraceptives for pregnancy prevention
  • Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial

Exclusion criteria

  • History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
  • History of allergy to TMC120 or to the constituents of the vaginal ring.
  • History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
  • History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
  • History of genital tract surgery within the last month
  • Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
  • Currently or within one month of participating in any other clinical research trial
  • Current (during screening) diagnosis of any genital infection
  • Current vulvar of vaginal symptoms
  • Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Treatment and study plan

placebo vaginal ring

Drug

vaginal ring containing no TMC120 (dapivirine)

TMC120 (dapivirine) vaginal ring

Drug

vaginal ring containing 120 mg TMC120 (dapivirine)

Primary outcomes

  1. safety and tolerability of a vaginal ring containing TMC120 (dapivirine)

    Time frame: 7 days

  2. TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

International Partnership for Microbicides, Inc.

Industry

Collaborators

  • Tibotec Pharmaceutical Limited

Registry information

Official study title

Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 18, 2008
Registry last updated
Sep 1, 2009

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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