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

A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Pravastatin; Drug: Pitavastatin

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, 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
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Coral Gables, Florida, United States
    • Fort Lauderdale, Florida, United States
    • Fort Pierce, Florida, United States
    • Miami, Florida, United States
    • Miami Beach, Florida, United States
    • Tampa, Florida, United States
    • Vero Beach, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Decatur, Georgia, United States
  • Massachusetts
    • Springfield, Massachusetts, United States
  • Michigan
    • Berkley, Michigan, United States
  • Missouri
    • St. Louis, Missouri, United States
  • New Jersey
    • Hillsborough, New Jersey, United States
    • Randolph, New Jersey, United States
  • New York
    • New York, New York, United States
    • Rochester, New York, United States
  • North Carolina
    • Huntersville, North Carolina, 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
  • Virginia
    • Annandale, Virginia, United States
  • Washington
    • Seattle, Washington, United States
    • Spokane, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pitavastatin 4 mg QD	Drug: Pitavastatin; Pitavastatin 4 mg QD; Other Names: Livalo
Active Comparator: Pravastatin 40 mg QD	Drug: Pravastatin; Pravastatin 40 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks	12 weeks minus baseline

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.
• Collaborators: Eli Lilly and Company; Kowa Pharmaceuticals America, Inc.

Publications and helpful links

General Publications

• 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. Erratum In: Lancet HIV. 2017 Jul;4(7):e283.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: March 27, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin; Pitavastatin
• Other Study ID Numbers: NK-104-4.05US