- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332995
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
August 31, 2009 updated by: International Partnership for Microbicides, Inc.
Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gent, Belgium, 9000
- Drug Research Unit Gent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dr. Luc Van Bortel, University of Ghent
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
June 1, 2006
First Submitted That Met QC Criteria
June 1, 2006
First Posted (ESTIMATE)
June 2, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 1, 2009
Last Update Submitted That Met QC Criteria
August 31, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dapivirine
Other Study ID Numbers
- IPM008, TMC120-C131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on dapivirine (TMC120) vaginal ring
-
International Partnership for Microbicides, Inc.Tibotec Pharmaceutical LimitedCompleted
-
International Partnership for Microbicides, Inc.National Institute of Allergy and Infectious Diseases (NIAID); National Institutes...CompletedHIV-1-infectionUnited States
-
International Partnership for Microbicides, Inc.Completed
-
International Partnership for Microbicides, Inc.Completed
-
International Partnership for Microbicides, Inc.CompletedHIV InfectionsSouth Africa, Uganda
-
International Partnership for Microbicides, Inc.Withdrawn
-
International Partnership for Microbicides, Inc.Completed
-
International Partnership for Microbicides, Inc.National Institute of Allergy and Infectious Diseases (NIAID)CompletedHuman Immunodeficiency VirusUnited States
-
International Partnership for Microbicides, Inc.National Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV InfectionsMalawi, South Africa, Uganda, Zimbabwe
-
International Partnership for Microbicides, Inc.CompletedHIV Infections | HIV-1Belgium