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A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469768
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : September 1, 2009
Information provided by:
International Partnership for Microbicides, Inc.

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: dapivirine reservoir intravaginal ring Drug: dapivirine matrix intravaginal ring Other: placebo intravaginal ring Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : May 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: A Drug: dapivirine matrix intravaginal ring
a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine

Experimental: B Drug: dapivirine reservoir intravaginal ring
a silicone elastomer reservoir ring containing 25mg of dapivirine

Placebo Comparator: C Other: placebo intravaginal ring
a silicone elastomer intravaginal ring containing no dapivirine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469768

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Drug Research Unit Ghent (D.R.U.G.)
Ghent, Belgium, 9000
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
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Study Director: Dr. Annalene Nel International Partnership for Microbicides (IPM)
Additional Information:
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Responsible Party: Zeda Rosenberg ScD, International Partnership for Microbicides Identifier: NCT00469768    
Other Study ID Numbers: IPM 018
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: September 1, 2009
Last Verified: August 2009
Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1 infection
HIV Seronegativity
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents