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

This study has been completed.

Sponsor:

Collaborator:

Tibotec Pharmaceutical Limited

Information provided by:

International Partnership for Microbicides, Inc.

ClinicalTrials.gov Identifier:

NCT00332995

First received: June 1, 2006

Last updated: August 31, 2009

Last verified: August 2009

History of Changes

Purpose

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.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

Resource links provided by NLM:

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 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).


Estimated Enrollment:	13
Study Start Date:	July 2005
Estimated Study Completion Date:	August 2005

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

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: NCT00332995

Locations


Belgium
Drug Research Unit Gent
Gent, Belgium, 9000

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Tibotec Pharmaceutical Limited

Investigators


Principal Investigator:	Dr. Luc Van Bortel	University of Ghent

More Information


Responsible Party:	Zeda Rosenberg ScD, International Partnership for Microbicides
ClinicalTrials.gov Identifier:	NCT00332995 History of Changes
Other Study ID Numbers:	IPM008, TMC120-C131
Study First Received:	June 1, 2006
Last Updated:	August 31, 2009
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment European Union: European Medicines Agency

Keywords provided by International Partnership for Microbicides, Inc.:


HIV Seronegativity

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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