A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
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
1 other identifier
interventional
252
1 country
35
Brief Summary
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2010
Typical duration for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
April 29, 2014
CompletedApril 29, 2014
March 1, 2014
2.2 years
February 18, 2011
February 10, 2014
March 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
12 weeks minus baseline
Study Arms (2)
Pitavastatin 4 mg QD
EXPERIMENTALPravastatin 40 mg QD
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Homozygous familial hypercholesterolemia
- Any conditions that may cause secondary dyslipidemia
- History of coronary artery disease (CAD) or CAD equivalent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kowa Research Institute, Inc.lead
- Kowa Pharmaceuticals America, Inc.collaborator
- Eli Lilly and Companycollaborator
Study Sites (35)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Newport Beach, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Ft. Pierce, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miami Beach, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Berkley, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Hillsborough, New Jersey, United States
Unknown Facility
Randolph Township, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Huntersville, North Carolina, United States
Unknown Facility
Addison, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Harlingen, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Longview, Texas, United States
Unknown Facility
Annandale, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Spokane, Washington, United States
Related Publications (3)
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.
PMID: 28416195DERIVEDToribio 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.
PMID: 28252528DERIVEDJoshi 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.
PMID: 28121706DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roger Morgan, MD, FACS
- Organization
- Kowa Research Institute, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 23, 2011
Study Start
December 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 29, 2014
Results First Posted
April 29, 2014
Record last verified: 2014-03