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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pitavastatin
Pravastatin
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pitavastatin 4 mg QD

Pravastatin 40 mg QD

Arm Description

Outcomes

Primary Outcome Measures

Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks

Secondary Outcome Measures

Full Information

First Posted
February 18, 2011
Last Updated
March 27, 2014
Sponsor
Kowa Research Institute, Inc.
Collaborators
Kowa Pharmaceuticals America, Inc., Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01301066
Brief Title
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.
Collaborators
Kowa Pharmaceuticals America, Inc., Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 4 mg QD
Arm Type
Experimental
Arm Title
Pravastatin 40 mg QD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Other Intervention Name(s)
Livalo
Intervention Description
Pitavastatin 4 mg QD
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Intervention Description
Pravastatin 40 mg QD
Primary Outcome Measure Information:
Title
Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
Time Frame
12 weeks minus baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Costa Mesa
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Newport Beach
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Coral Gables
State/Province
Florida
Country
United States
City
Fort Lauderdale
State/Province
Florida
Country
United States
City
Fort Pierce
State/Province
Florida
Country
United States
City
Miami Beach
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Vero Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Decatur
State/Province
Georgia
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Berkley
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Hillsborough
State/Province
New Jersey
Country
United States
City
Randolph
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Huntersville
State/Province
North Carolina
Country
United States
City
Addison
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Harlingen
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Longview
State/Province
Texas
Country
United States
City
Annandale
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28416195
Citation
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.
Results Reference
derived
PubMed Identifier
28252528
Citation
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.
Results Reference
derived
PubMed Identifier
28121706
Citation
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.
Results Reference
derived

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

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