A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
NCT ID: NCT01301066
Last Updated: 2014-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
252 participants
INTERVENTIONAL
2010-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pitavastatin 4 mg QD
Pitavastatin
Pitavastatin 4 mg QD
Pravastatin 40 mg QD
Pravastatin
Pravastatin 40 mg QD
Interventions
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Pitavastatin
Pitavastatin 4 mg QD
Pravastatin
Pravastatin 40 mg QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \>40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
* Documented HIV infection.
Exclusion Criteria
* Any conditions that may cause secondary dyslipidemia
* History of coronary artery disease (CAD) or CAD equivalent
18 Years
70 Years
ALL
No
Sponsors
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Kowa Pharmaceuticals America, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Beverly Hills, California, United States
Costa Mesa, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Coral Gables, Florida, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Springfield, Massachusetts, United States
Berkley, Michigan, United States
St Louis, Missouri, United States
Hillsborough, New Jersey, United States
Randolph Township, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Huntersville, North Carolina, United States
Addison, Texas, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Fort Worth, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Annandale, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Countries
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References
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Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.
Toribio M, Fitch KV, Sanchez L, Burdo TH, Williams KC, Sponseller CA, McCurdy Pate M, Aberg JA, Zanni MV, Grinspoon SK. Effects of pitavastatin and pravastatin on markers of immune activation and arterial inflammation in HIV. AIDS. 2017 Mar 27;31(6):797-806. doi: 10.1097/QAD.0000000000001427.
Joshi PH, Miller PE, Martin SS, Jones SR, Massaro JM, D'Agostino RB Sr, Kulkarni KR, Sponseller C, Toth PP. Greater remnant lipoprotein cholesterol reduction with pitavastatin compared with pravastatin in HIV-infected patients. AIDS. 2017 Apr 24;31(7):965-971. doi: 10.1097/QAD.0000000000001423.
Other Identifiers
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NK-104-4.05US
Identifier Type: -
Identifier Source: org_study_id
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