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

Primary Purpose

HIV, Hypercholesterolaemia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Switch ritonavir-boosted PI
Continue Ritonavir-boosted PI+Rosuvastatin
Sponsored by
Juan A. Arnaiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Hypercholesterolaemia, HIV, Rosuvastatin, Protease inhibitor switching

Eligibility Criteria

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

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

Sites / Locations

  • Hospital Clinic of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Switch ritonavir-boosted PI

Continue ritonavir-boosted PI+Rosuvastatin

Arm Description

Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.

Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).

Outcomes

Primary Outcome Measures

Percentage change from baseline in total cholesterol at 12 weeks.

Secondary Outcome Measures

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.

Full Information

First Posted
March 19, 2013
Last Updated
October 7, 2014
Sponsor
Juan A. Arnaiz
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1. Study Identification

Unique Protocol Identification Number
NCT01935674
Brief Title
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
Acronym
SOS
Official Title
Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hypercholesterolaemia
Keywords
Hypercholesterolaemia, HIV, Rosuvastatin, Protease inhibitor switching

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Switch ritonavir-boosted PI
Arm Type
Experimental
Arm Description
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Arm Title
Continue ritonavir-boosted PI+Rosuvastatin
Arm Type
Experimental
Arm Description
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Intervention Type
Drug
Intervention Name(s)
Switch ritonavir-boosted PI
Intervention Description
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Intervention Type
Drug
Intervention Name(s)
Continue Ritonavir-boosted PI+Rosuvastatin
Intervention Description
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Primary Outcome Measure Information:
Title
Percentage change from baseline in total cholesterol at 12 weeks.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol through week 12
Time Frame
12 weeks
Title
Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
Time Frame
12 weeks
Title
Quality of life (SF-12)
Time Frame
12 weeks
Title
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
Title
Fasting glucose and insulin.
Time Frame
12 weeks
Title
Framingham cardiovascular risk score.
Time Frame
Screening and week 12.
Title
D:A:D 5-year estimated risk calculator.
Time Frame
Screening and week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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) other immunosuppressive or immunomodulating drugs Contraindication to rosuvastatin therapy: liver transaminases >5 times the upper normal limit creatinine clearance <30 mL/min known myopathy current fibrate therapy 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esteban Martinez, MD
Organizational Affiliation
Hospital Clínic i Provincial de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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

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