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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

March 19, 2013
October 7, 2014
September 2013
September 2014   (final data collection date for primary outcome measure)
Percentage change from baseline in total cholesterol at 12 weeks. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01935674 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Hypercholesterolaemia
  • 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.
  • Drug: Continue Ritonavir-boosted PI+Rosuvastatin
    Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
  • 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.
    Intervention: Drug: Switch ritonavir-boosted PI
  • Experimental: Continue ritonavir-boosted PI+Rosuvastatin
    Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).     
    Intervention: Drug: Continue Ritonavir-boosted PI+Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01935674
SOS
Yes
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Principal Investigator: Esteban Martinez, MD Hospital Clínic i Provincial de Barcelona
Hospital Clinic of Barcelona
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP