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

Primary Purpose

HIV Infection, Coronary Heart Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Pravastatin

Rosuvastatin

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 <15.0%.
Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.
History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent
Statin absolute contraindication
Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater
Chronic kidney disease stage 4 or greater (including dialysis)
Systolic heart failure with last documented LVEF <35%
Pregnant or breastfeeding
Laboratory values obtained within 45 days prior to study entry:

LDL-c <80 mg/dl while not on statin or LDL-c <60 mg/dl while on statin ALT > 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

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate Intensity Group

High Intensity Group

Arm Description

pravastatin 40mg daily for 12 weeks

rosuvastatin 20 - 40 mg daily for 12 weeks

Outcomes

Primary Outcome Measures

Mean Percent Change in Fasting LDL-cholesterol

Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14

Treatment-emergent Adverse Events

Number of Grade 3 or above adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT02841774

First Posted

July 14, 2016

Last Updated

September 26, 2022

Sponsor

Matthew Feinstein

1. Study Identification

Unique Protocol Identification Number

NCT02841774

Brief Title

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

Acronym

HILLCLIMBER

Official Title

High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With Human Immunodeficiency Virus (HILLCLIMBER)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

June 2021 (Actual)

Study Completion Date

June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Matthew Feinstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed Description

HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy versus high-dose statin therapy in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD). All subjects will have an initial 2-week run-in period with pravastatin 40mg daily (Week 0 to 2). Subjects not demonstrating significant toxicity at week 2 will then be randomized to rosuvastatin 20mg (high intensity dose group) versus continuing pravastatin 40mg daily (moderate intensity group) for 12 weeks (Weeks 2 to 14). At week 6, those in the rosuvastatin arm who do not demonstrate significant toxicity and whose LDL-c is >60mg/dl and decreased by less than 25% compared with week 2 will then have doses increased to rosuvastatin 40mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection, Coronary Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moderate Intensity Group

Arm Type

Active Comparator

Arm Description

pravastatin 40mg daily for 12 weeks

Arm Title

High Intensity Group

Arm Type

Experimental

Arm Description

rosuvastatin 20 - 40 mg daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Pravastatin

Intervention Description

40mg daily (Weeks 2 - 14)

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

CRESTOR

Intervention Description

20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK <+1.5 x ULN, and LDL-c is >60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily

Primary Outcome Measure Information:

Title

Mean Percent Change in Fasting LDL-cholesterol

Description

Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14

Time Frame

Week 2 and Week 14

Title

Treatment-emergent Adverse Events

Description

Number of Grade 3 or above adverse events

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 <15.0%. Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir. History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent Statin absolute contraindication Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater Chronic kidney disease stage 4 or greater (including dialysis) Systolic heart failure with last documented LVEF <35% Pregnant or breastfeeding Laboratory values obtained within 45 days prior to study entry: LDL-c <80 mg/dl while not on statin or LDL-c <60 mg/dl while on statin ALT > 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald Lloyd-Jones, MD

Organizational Affiliation

Northwestern University

Official's Role

Study Chair

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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