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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00764946 |
A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with HIV, where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.
Condition | Intervention | Phase |
---|---|---|
Human Immunodeficiency Virus |
Drug: Comparator: raltegravir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients |
Estimated Enrollment: | 200 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
raltegravir
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Drug: Comparator: raltegravir
400 mg tablets taken twice daily. Total treatment period is 48 weeks.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
United States, Arizona | |
Call for Information | Recruiting |
Phoenix, Arizona, United States, 85006 | |
United States, California | |
Call for Information | Recruiting |
Torrance, California, United States, 90502 | |
United States, District of Columbia | |
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Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
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West Palm Beach, Florida, United States, 33401 | |
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Orlando, Florida, United States, 32803 | |
Call for Information | Recruiting |
Miami, Florida, United States, 33137 | |
Call for Information | Recruiting |
Hialeah, Florida, United States, 33012 | |
United States, Georgia | |
Call for Information | Recruiting |
Savannah, Georgia, United States, 31410 | |
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Atlanta, Georgia, United States, 30308-1923 | |
United States, Illinois | |
Call for Information | Recruiting |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
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Baltimore, Maryland, United States, 21201-0000 | |
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Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
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Boston, Massachusetts, United States, 02115-0000 | |
United States, Missouri | |
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St. Louis, Missouri, United States, 63108 | |
United States, New Jersey | |
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Newark, New Jersey, United States, 07103 | |
United States, New York | |
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Rochester, New York, United States, 14604 | |
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Albany, New York, United States, 12208 | |
United States, Pennsylvania | |
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Philadelphia, Pennsylvania, United States, 19107 | |
United States, South Carolina | |
Call for Information | Recruiting |
Columbia, South Carolina, United States, 29203 | |
United States, Texas | |
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Houston, Texas, United States, 77004 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_555, MK0518-055 |
Study First Received: | October 1, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00764946 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections |