Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels (SOS)

Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults

To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.

Study Overview

• Status: Completed
• Conditions: HIV; Hypercholesterolaemia
• Intervention / Treatment: Drug: Switch ritonavir-boosted PI; Drug: Continue Ritonavir-boosted PI+Rosuvastatin

Detailed Description

To compare the effects of rosuvastatin to protease inhibitor switching on:

• Total cholesterol through week 12
• Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
• Quality of life (SF-12)
• Fasting LDL cholesterol (estimated with Friedewald equation unless triglycerides >400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides
• Fasting glucose and insulin
• Framingham cardiovascular risk score
• D:A:D 5-year estimated risk calculator

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HIV-positive status
• Adults (≥18 years of age)
• Stable and well-tolerated combination ART including a ritonavir-boosted protease inhibitor for the previous 6 months
• HIV RNA <50 copies/mL for at least the preceding 3 months
• Fasting total cholesterol ≥5.5 mmol/L (>213 mg/dL)
• Framingham risk score ≥8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
• Provision of written, informed consent

Exclusion criteria:

• Any statin in the previous 12 weeks
• Previous statin-induced myopathy or hepatitis
• History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)

• Concurrent use of:

  1. oral corticosteroids use other than for replacement therapy (i.e. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
  2. other immunosuppressive or immunomodulating drugs

• Contraindication to rosuvastatin therapy:

  1. liver transaminases >5 times the upper normal limit
  2. creatinine clearance <30 mL/min
  3. known myopathy
  4. current fibrate therapy
  5. known resistance to one or more "backbone" ART drugs
• No potent switch ART drug available to replace the current ritonavir-boosted protease inhibitor
• Known intolerance to rosuvastatin or the proposed switch ART drug
• Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
• A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
• Unable to complete study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Switch ritonavir-boosted PI; Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.	Drug: Switch ritonavir-boosted PI; Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Experimental: Continue ritonavir-boosted PI+Rosuvastatin; Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).	Drug: Continue Ritonavir-boosted PI+Rosuvastatin; Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in Total Cholesterol at 12 Weeks.	The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis.	12 weeks from baseline (week 0 to week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cholesterol Through Week 12		12 weeks
Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy)		12 weeks
Quality of Life (SF-12)		12 weeks
Fasting LDL Cholesterol (Estimated With Friedewald Equation Unless Triglycerides >400mg/dL, in Which Case LDL-C Would be Measured Directly), HDL Cholesterol, Total : HDL Cholesterol Ratio, LDL Particles Sizes, Triglycerides		12 weeks
Fasting Glucose and Insulin.		12 weeks
Framingham Cardiovascular Risk Score (10-year Risk Estimate)	The Framingham Risk Score is a sex-specific algorithm used to estimate the 10-year risk of developing cardiovascular disease (CVD), including coronary heart disease, stroke, peripheral artery disease, and heart failure. It is based on factors such as age, sex, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for hypertension, smoking status, and diabetes. Scale Title: Framingham 10-Year Cardiovascular Risk Score Minimum Value: 0% Maximum Value: 100% Interpretation: Higher scores indicate a worse outcome, meaning a higher estimated risk of developing cardiovascular disease within 10 years.	Screening and week 12
D:A:D 5-year Estimated Risk Calculator.		Screening and week 12.

Collaborators and Investigators

• Sponsor: Juan A. Arnaiz
• Investigators: Principal Investigator: Esteban Martinez, MD, Hospital Clinic of Barcelona

Publications and helpful links

Helpful Links

• Rosuvastatin vs. protease inhibitor switching for hypercholesterolaemia: a randomized trial

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: September 2, 2013
• First Posted (Estimated): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Rosuvastatin; Hypercholesterolaemia; Protease inhibitor switching
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Viral Protease Inhibitors; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antimetabolites; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Ritonavir
• Other Study ID Numbers: SOS