- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00469768
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
August 31, 2009 updated by: International Partnership for Microbicides, Inc.
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
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ghent, Belgium, 9000
- Drug Research Unit Ghent (D.R.U.G.)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: C
|
a silicone elastomer intravaginal ring containing no dapivirine
|
Experimental: A
|
a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
|
Experimental: B
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a silicone elastomer reservoir ring containing 25mg of dapivirine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dr. Annalene Nel, International Partnership for Microbicides (IPM)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
May 3, 2007
First Submitted That Met QC Criteria
May 3, 2007
First Posted (Estimate)
May 4, 2007
Study Record Updates
Last Update Posted (Estimate)
September 1, 2009
Last Update Submitted That Met QC Criteria
August 31, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dapivirine
Other Study ID Numbers
- IPM 018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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