A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium

This study has been completed.

Sponsored by:	International Partnership for Microbicides, Inc.
Information provided by:	International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:	NCT00309205

Purpose

Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.

Condition	Intervention	Phase
HIV Infections HIV-1	Drug: dapivirine (TMC120) vaginal gel	Phase I Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Dapivirine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel Vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

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

Primary Outcome Measures:

Local and systemic safety and tolerability.

Estimated Enrollment:	36
Study Start Date:	December 2005

Eligibility

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

Criteria

Inclusion Criteria:

HIV-negative
Willing to participate and sign an informed consent form
Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
Willing to use two forms of contraception during the study
Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

Exclusion Criteria:

Currently pregnant or breast-feeding
Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309205

Locations

Belgium
SGS Biopharma - Research Unit Stuivenberg
Antwerp, Belgium, 2060

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director:

Zeda Rosenberg, ScD

IPM

More Information

Study ID Numbers:	IPM005B
Study First Received:	March 30, 2006
Last Updated:	July 24, 2006
ClinicalTrials.gov Identifier:	NCT00309205
Health Authority:	Belgium: Federal Public Service Health, Food Chain and Environment; Europe: European Medicines Agency

Keywords provided by International Partnership for Microbicides, Inc.:

HIV seronegativity

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009