search
Back to results

A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
dapivirine reservoir intravaginal ring
dapivirine matrix intravaginal ring
placebo intravaginal 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-1 infection, HIV Seronegativity

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women between 18 and 35 years of age
  • Willing and able to give written informed consent
  • Available for all visits and consent to follow all procedures scheduled for the study
  • Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
  • Willing to abstain from sexual activity for the duration of the study
  • Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment
  • Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal
  • Willing to refrain from use of vaginal products or objects for the duration of the study.

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 sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
  • Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
  • Currently or within one month of participating in any other clinical research study
  • History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
  • History of genital tract surgery within the last month
  • Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas)
  • Current vulvar or vaginal symptoms / abnormalities that could influence the study results
  • History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months;
  • Smoking more than 10 cigarettes per day

Sites / Locations

  • Drug Research Unit Ghent (D.R.U.G.)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 3, 2007
Last Updated
August 31, 2009
Sponsor
International Partnership for Microbicides, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00469768
Brief Title
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
Official Title
A Double-blind, Randomized, Placebo-controlled Safety and Pharmacokinetic Study in Healthy HIV-negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Partnership for Microbicides, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
dapivirine reservoir intravaginal ring
Intervention Description
a silicone elastomer reservoir ring containing 25mg of dapivirine
Intervention Type
Drug
Intervention Name(s)
dapivirine matrix intravaginal ring
Intervention Description
a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
Intervention Type
Other
Intervention Name(s)
placebo intravaginal ring
Intervention Description
a silicone elastomer intravaginal ring containing no dapivirine

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women between 18 and 35 years of age Willing and able to give written informed consent Available for all visits and consent to follow all procedures scheduled for the study Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment; Willing to abstain from sexual activity for the duration of the study Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal Willing to refrain from use of vaginal products or objects for the duration of the study. 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 sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer) Currently pregnant or breast-feeding, or within three months of last pregnancy outcome Currently or within one month of participating in any other clinical research study History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months History of genital tract surgery within the last month Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas) Current vulvar or vaginal symptoms / abnormalities that could influence the study results History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months; Smoking more than 10 cigarettes per day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Annalene Nel
Organizational Affiliation
International Partnership for Microbicides (IPM)
Official's Role
Study Director
Facility Information:
Facility Name
Drug Research Unit Ghent (D.R.U.G.)
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.drug-uzgent.be
Description
Drug Research Unit Ghent website

Learn more about this trial

A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

We'll reach out to this number within 24 hrs