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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00067782 |
The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Atazanavir (immediate switch) Drug: Atazanavir (Week 24 switch) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Study Start Date: | December 2002 |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
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2: Active Comparator |
Drug: Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Any of the following:
i) pause length > 3 seconds ii) second or third degree AV heart block iii) QTc interval > 450 msec for males iv) QTc interval > 470 msec for females
Any of the following lab values within 2 weeks of starting study drug:
United States, Arizona | |
Local Institution | |
Phoenix, Arizona, United States | |
United States, California | |
Local Institution | |
West Hollywood, California, United States | |
United States, District of Columbia | |
Local Institution | |
Washington, District of Columbia, United States | |
United States, Florida | |
Local Institution | |
Ft. Lauderdale, Florida, United States | |
Local Institution | |
Tampa, Florida, United States | |
Local Institution | |
Miami, Florida, United States | |
Local Institution | |
Altamonte Springs, Florida, United States | |
United States, Massachusetts | |
Local Institution | |
Boston, Massachusetts, United States | |
United States, Minnesota | |
Local Institution | |
Minneapolis, Minnesota, United States | |
United States, Missouri | |
Local Institution | |
St. Louis, Missouri, United States | |
United States, New Jersey | |
Local Institution | |
East Orange, New Jersey, United States | |
United States, New York | |
Local Institution | |
New York, New York, United States | |
United States, North Carolina | |
Local Institution | |
Huntersville, North Carolina, United States | |
United States, Ohio | |
Local Institution | |
Cleveland, Ohio, United States | |
United States, Oklahoma | |
Local Institution | |
Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
Local Institution | |
Philadelphia, Pennsylvania, United States | |
United States, South Carolina | |
Local Institution | |
Columbia, South Carolina, United States | |
United States, Texas | |
Local Institution | |
Houston, Texas, United States | |
Local Institution | |
Fort Worth, Texas, United States |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study ID Numbers: | AI424-067 |
Study First Received: | August 27, 2003 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00067782 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Treatment Experienced |
Anti-Infective Agents Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents |
Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Atazanavir Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |