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

Phase 4

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Pitavastatin; Drug: Pravastatin

• 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

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-02-10
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-27
• Last Update Submitted: 2014-03-27
• Results First Posted: 2014-04-29
• Last Update Posted: 2014-04-29

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.

Exclusion Criteria

• Homozygous familial hypercholesterolemia
• Any conditions that may cause secondary dyslipidemia
• History of coronary artery disease (CAD) or CAD equivalent

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