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| Sponsor: | International Partnership for Microbicides, Inc. |
|---|---|
| Information provided by: | International Partnership for Microbicides, Inc. |
| ClinicalTrials.gov Identifier: | NCT00799058 |
Purpose
IPM 020 is a double-blind, randomized, placebo-controlled Phase I/II expanded safety trial being conducted at 5 research centers in the United States among approximately 180 healthy, sexually active, HIV-negative women to assess the safety of Dapivirine Gel 4759, 0.05% 2.5g and Dapivirine Gel 4789, 0.05% 2.5g as compared to the HEC-based universal placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infections |
Drug: dapivirine Drug: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Double-blind, Randomized, Placebo-controlled Phase I/II Trial to Evaluate the Safety of Dapivirine Gel, 0.05%, 2.5g and Dapivirine Gel 2759, 0.05%, 2.5g Formulations as Compared to the Vaginal HEC-based Universal Placebo Gel, 2.5g in Healthy, HIV-negative Women. |
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: dapivirine gel 4789 |
Drug: dapivirine
dapivirine gel 4789, 0.05%, 2.5g applied once daily
Other Name: TMC120
|
| Active Comparator: dapivirine gel 4759 |
Drug: dapivirine
dapivirine gel 4759, 0.05%, 2.5g applied once daily
Other Name: TMC120
|
| Placebo Comparator: placebo gel |
Drug: placebo
HEC-based universal placebo gel, 2.5g applied once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Willing to abstain from all the following criteria beginning 48 hours prior to each trial visit:
Willing to abstain from all of the following for 3 days after biopsy procedures:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS) | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| SNBL Clinical Pharmacology Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New York | |
| Albert Einstein College of Medicine | |
| New York, New York, United States, 10461 | |
| Study Chair: | Dr Annalene Nel | International Partnership for Microbicides |
More Information
| Responsible Party: | Zeda Rosenberg, International Partnership for Microbicides |
| ClinicalTrials.gov Identifier: | NCT00799058 History of Changes |
| Other Study ID Numbers: | IPM 020 |
| Study First Received: | November 26, 2008 |
| Last Updated: | June 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 infections |
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |