A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
- Registration Number
- NCT01301066
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
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.
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Exclusion Criteria
- Homozygous familial hypercholesterolemia
- Any conditions that may cause secondary dyslipidemia
- History of coronary artery disease (CAD) or CAD equivalent
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pitavastatin 4 mg QD Pitavastatin - Pravastatin 40 mg QD Pravastatin -
- Primary Outcome Measures
Name Time Method Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks 12 weeks minus baseline
- Secondary Outcome Measures
Name Time Method