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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01935674
First received: March 19, 2013
Last updated: October 7, 2014
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
HIV
Hypercholesterolaemia
Drug: Switch ritonavir-boosted PI
Drug: Continue Ritonavir-boosted PI+Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Percentage change from baseline in total cholesterol at 12 weeks. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cholesterol through week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life (SF-12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fasting glucose and insulin. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Framingham cardiovascular risk score. [ Time Frame: Screening and week 12. ] [ Designated as safety issue: No ]
  • D:A:D 5-year estimated risk calculator. [ Time Frame: Screening and week 12. ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935674

Locations
Spain
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
Principal Investigator: Esteban Martinez, MD Hospital Clínic i Provincial de Barcelona
  More Information

No publications provided

Responsible Party: Juan A. Arnaiz, Project manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01935674     History of Changes
Other Study ID Numbers: SOS
Study First Received: March 19, 2013
Last Updated: October 7, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Clinic of Barcelona:
Hypercholesterolaemia
HIV
Rosuvastatin
Protease inhibitor switching

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
HIV Protease Inhibitors
Protease Inhibitors
Ritonavir
Rosuvastatin
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Anticholesteremic Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014