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A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01301066
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Pitavastatin Drug: Pravastatin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study
Study Start Date : December 2010
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pitavastatin 4 mg QD Drug: Pitavastatin
Pitavastatin 4 mg QD
Other Name: Livalo
Active Comparator: Pravastatin 40 mg QD Drug: Pravastatin
Pravastatin 40 mg QD


Outcome Measures

Primary Outcome Measures :
  1. Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks [ Time Frame: 12 weeks minus baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
  • 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:

  • Homozygous familial hypercholesterolemia
  • Any conditions that may cause secondary dyslipidemia
  • History of coronary artery disease (CAD) or CAD equivalent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301066


  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
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
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Coral Gables, Florida, United States
Fort Lauderdale, Florida, United States
Fort Pierce, Florida, United States
Miami Beach, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Decatur, Georgia, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Berkley, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Jersey
Hillsborough, New Jersey, United States
Randolph, New Jersey, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
Huntersville, North Carolina, United States
United States, Texas
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
United States, Virginia
Annandale, Virginia, United States
United States, Washington
Seattle, Washington, United States
Spokane, Washington, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
More Information

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01301066     History of Changes
Other Study ID Numbers: NK-104-4.05US
First Posted: February 23, 2011    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors