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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Juan A. Arnaiz


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
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults

Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Primary Outcome Measures

  • Percentage change from baseline in total cholesterol at 12 weeks. [ Time Frame: Baseline and 12 weeks ]
Secondary Outcome Measures:
  • Total cholesterol through week 12 [ Time Frame: 12 weeks ]
  • Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy) [ Time Frame: 12 weeks ]
  • Quality of life (SF-12) [ Time Frame: 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 [ Time Frame: 12 weeks ]
  • Fasting glucose and insulin. [ Time Frame: 12 weeks ]
  • Framingham cardiovascular risk score. [ Time Frame: Screening and week 12. ]
  • D:A:D 5-year estimated risk calculator. [ Time Frame: Screening and week 12. ]

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
5-year estimated risk calculator

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


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  

Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Hypercholesterolaemia
HIV
Rosuvastatin
Protease inhibitor switching

Additional relevant MeSH terms:
Hypercholesterolemia
Ritonavir
HIV Protease Inhibitors
Rosuvastatin Calcium
Protease Inhibitors

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.