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

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00700284
First received: June 16, 2008
Last updated: August 31, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: placebo vaginal ring
Drug: TMC120 (dapivirine) vaginal ring
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • safety and tolerability of a vaginal ring containing TMC120 (dapivirine) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: placebo vaginal ring
vaginal ring containing no TMC120 (dapivirine)
Experimental: B Drug: TMC120 (dapivirine) vaginal ring
vaginal ring containing 120 mg TMC120 (dapivirine)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700284

Locations
Belgium
Drug Research Unit, UZ Gent
Gent, Belgium, 9000
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Tibotec Pharmaceutical Limited
Investigators
Principal Investigator: Dr Luc Van Bortel Drug Research Unit, UZ Gent
  More Information

No publications provided

Responsible Party: Zeda Rosenberg ScD, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT00700284     History of Changes
Other Study ID Numbers: IPM 001, TMC120-C130
Study First Received: June 16, 2008
Last Updated: August 31, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by International Partnership for Microbicides, Inc.:
HIV-I
Reverse transcriptase inhibitors
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014