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Sponsored by: |
International Partnership for Microbicides, Inc. |
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Information provided by: | International Partnership for Microbicides, Inc. |
ClinicalTrials.gov Identifier: | NCT00469768 |
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 | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: dapivirine reservoir intravaginal ring Drug: dapivirine matrix intravaginal ring Other: placebo intravaginal ring |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study |
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 |
Enrollment: | 24 |
Study Start Date: | May 2007 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
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A: Experimental |
Drug: dapivirine matrix intravaginal ring
a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
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B: Experimental |
Drug: dapivirine reservoir intravaginal ring
a silicone elastomer reservoir ring containing 25mg of dapivirine
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C: Placebo Comparator |
Other: placebo intravaginal ring
a silicone elastomer intravaginal ring containing no dapivirine
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Drug Research Unit Ghent (D.R.U.G.) | |
Ghent, Belgium, 9000 |
Study Director: | Dr. Annalene Nel | International Partnership for Microbicides (IPM) |
Study ID Numbers: | IPM 018 |
Study First Received: | May 3, 2007 |
Last Updated: | September 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00469768 |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
HIV-1 infection HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |