Phase 4
Completed N=252
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
Source: ClinicalTrials.gov NCT01301066 ↗Enrolled (actual)
252
Serious AEs
4.0%
Results posted
Apr 2014
Primary outcomePrimary: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks — 155.1; 154.6 mg/dL
Summary
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks |
155.1; 154.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT01301066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.