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

Kowa

Status and phase: Completed; Phase 4

Conditions: Dyslipidemia

Treatments: Drug: Pravastatin; Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301066

NK-104-4.05US

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

Pitavastatin 4 mg QD

Experimental group

Treatment:

Drug: Pitavastatin

Pravastatin 40 mg QD

Active Comparator group

Treatment:

Drug: Pravastatin