Trial record 13 of 45 for:
" June 03, 2008":" July 03, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
This study has been completed.
Sponsor:
International Partnership for Microbicides, Inc.
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 June 17, 2013