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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

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