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Completed

NCT Number: NCT00332995

Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

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

Exclusion criteria

  • History of allergy to TMC120 or to the constituents of the vaginal ring
  • 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 study
  • Current vulvar or vaginal symptoms / abnormalities that could influence the study results
  • Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
  • Current diagnosis of any genital infection
  • Smoking more than 10 cigarettes / day

Treatment and study plan

dapivirine (TMC120) vaginal ring

Drug

Primary outcomes

  1. Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).

  2. Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120).

Sponsors and collaborators

Lead sponsor

International Partnership for Microbicides, Inc.

Industry

Collaborators

  • Tibotec Pharmaceutical Limited

Registry information

Official study title

Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

Important dates

Study start
2005
Study completion
2005
First posted
Jun 2, 2006
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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