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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 30, 2006

Last Updated Date

July 24, 2006

Start Date ^†

December 2005

Current Primary Outcome Measures ^†

Local and systemic safety and tolerability.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00309205 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Condition ^†

HIV Infections
HIV-1

Intervention ^†

Drug: dapivirine (TMC120) vaginal gel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309205

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

International Partnership for Microbicides, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Zeda Rosenberg, ScD

IPM

Information Provided By

International Partnership for Microbicides, Inc.

Verification Date

June 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.