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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
dapivirine (TMC120) vaginal ring
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: 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

Sites / Locations

  • Drug Research Unit Gent

Outcomes

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).

Secondary Outcome Measures

Full Information

First Posted
June 1, 2006
Last Updated
August 31, 2009
Sponsor
International Partnership for Microbicides, Inc.
Collaborators
Tibotec Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00332995
Brief Title
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
Official Title
Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
International Partnership for Microbicides, Inc.
Collaborators
Tibotec Pharmaceutical Limited

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dapivirine (TMC120) vaginal ring
Primary Outcome Measure Information:
Title
Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).
Title
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).

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Luc Van Bortel
Organizational Affiliation
University of Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drug Research Unit Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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

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