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Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

Primary Purpose

HIV Infections

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

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV-I, Reverse transcriptase inhibitors, HIV Seronegativity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female, 18-50 years, inclusive
  • Willing and able to provide written informed consent
  • HIV-uninfected and otherwise healthy
  • Willing to abstain from sexual activity and use of vaginal products while participating in the trial
  • Currently using oral contraceptives for pregnancy prevention
  • Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial

Exclusion Criteria:

  • History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
  • History of allergy to TMC120 or to the constituents of the vaginal ring.
  • History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
  • 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 trial
  • Current (during screening) diagnosis of any genital infection
  • Current vulvar of vaginal symptoms
  • Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Sites / Locations

  • Drug Research Unit, UZ Gent

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma

Secondary Outcome Measures

Full Information

First Posted
June 16, 2008
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
NCT00700284
Brief Title
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
Official Title
Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-I, Reverse transcriptase inhibitors, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo vaginal ring
Intervention Description
vaginal ring containing no TMC120 (dapivirine)
Intervention Type
Drug
Intervention Name(s)
TMC120 (dapivirine) vaginal ring
Intervention Description
vaginal ring containing 120 mg TMC120 (dapivirine)
Primary Outcome Measure Information:
Title
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
Time Frame
7 days
Title
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
Time Frame
7 days

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, 18-50 years, inclusive Willing and able to provide written informed consent HIV-uninfected and otherwise healthy Willing to abstain from sexual activity and use of vaginal products while participating in the trial Currently using oral contraceptives for pregnancy prevention Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial Exclusion Criteria: History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements. History of allergy to TMC120 or to the constituents of the vaginal ring. History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation 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 trial Current (during screening) diagnosis of any genital infection Current vulvar of vaginal symptoms Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Luc Van Bortel
Organizational Affiliation
Drug Research Unit, UZ Gent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drug Research Unit, UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

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