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

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.
 
ClinicalTrials.gov Identifier: NCT00700284
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : September 1, 2009
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
International Partnership for Microbicides, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: placebo vaginal ring Drug: TMC120 (dapivirine) vaginal ring Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide
Study Start Date : October 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00700284


Locations
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Belgium
Drug Research Unit, UZ Gent
Gent, Belgium, 9000
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Tibotec Pharmaceutical Limited
Investigators
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Principal Investigator: Dr Luc Van Bortel Drug Research Unit, UZ Gent
More Information
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Responsible Party: Zeda Rosenberg ScD, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT00700284    
Other Study ID Numbers: IPM 001, TMC120-C130
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: September 1, 2009
Last Verified: August 2009
Keywords provided by International Partnership for Microbicides, Inc.:
HIV-I
Reverse transcriptase inhibitors
HIV Seronegativity
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Dapivirine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents