Phase 2 Completed N=10 Randomized Treatment

High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV

HIV · Heart Failure

Source: ClinicalTrials.gov NCT02841774 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcomePrimary: Mean Percent Change in Fasting LDL-cholesterol — 15.0; 41.6 Percent decrease

Summary

HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percent Change in Fasting LDL-cholesterol	15.0; 41.6	—
PRIMARY Treatment-emergent Adverse Events	0; 0	—

Eligibility Criteria

Inclusion Criteria

HIV-1 infection
HIV RNA below the lower limit of assay detection within 12 months of study entry
1) Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator
Negative serum or urine pregnancy test
Men and women age 18 to 75 years of age

Exclusion Criteria

Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
No coronary heart disease (CHD) and 10-year ASCVD risk 3 x Upper Limit of Normal (ULN) AST > 3 x ULN Creatinine kinase (CK) >3 x ULN (calculated creatinine clearance (CrCl) <50 mL/min, as estimated by the Cockcroft-Gault equation)
Life expectancy <12 months
Prior organ transplant
Active malignancy
Inflammatory muscle disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02841774). 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.