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

Primary Purpose

HIV Infections, HIV-1

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
dapivirine (TMC120) vaginal gel
Sponsored by
International Partnership for Microbicides, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV seronegativity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • SGS Biopharma - Research Unit Stuivenberg

Outcomes

Primary Outcome Measures

Local and systemic safety and tolerability.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2006
Last Updated
August 31, 2009
Sponsor
International Partnership for Microbicides, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00309205
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
International Partnership for Microbicides, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV-1
Keywords
HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dapivirine (TMC120) vaginal gel
Primary Outcome Measure Information:
Title
Local and systemic safety and tolerability.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeda Rosenberg, ScD
Organizational Affiliation
IPM
Official's Role
Study Director
Facility Information:
Facility Name
SGS Biopharma - Research Unit Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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