Clinical trial NCT01301066: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kowa Pharmaceuticals America, Inc.
name: Eli Lilly and Company
First posted: 2011-02-23
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
timeFrame: 12 weeks minus baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Coral Gables
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Pierce
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Springfield
country: United States
state: Massachusetts
city: Berkley
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Hillsborough
country: United States
state: New Jersey
city: Randolph
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Huntersville
country: United States
state: North Carolina
city: Addison
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Harlingen
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
References:
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.
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.
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.