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

This study has been completed.

Sponsor:

Information provided by:

International Partnership for Microbicides, Inc.

ClinicalTrials.gov Identifier:

NCT00309205

First received: March 30, 2006

Last updated: August 31, 2009

Last verified: August 2009

History of Changes

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention
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.

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:

Local and systemic safety and tolerability.


Estimated Enrollment:	36
Study Start Date:	December 2005

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes 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

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: 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


Responsible Party:	Zeda Rosenberg ScD, International Partnership for Microbicides
ClinicalTrials.gov Identifier:	NCT00309205 History of Changes
Other Study ID Numbers:	IPM005B
Study First Received:	March 30, 2006
Last Updated:	August 31, 2009

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 Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017

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