Clinical trial NCT01935674: Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
Official title: Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Hypercholesterolaemia
Keywords: Hypercholesterolaemia
HIV
Rosuvastatin
Protease inhibitor switching
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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:

  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

Primary outcomes:
measure: Percentage change from baseline in total cholesterol at 12 weeks.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Total cholesterol through week 12
timeFrame: 12 weeks
measure: Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
timeFrame: 12 weeks
measure: Quality of life (SF-12)
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Fasting glucose and insulin.
timeFrame: 12 weeks
measure: Framingham cardiovascular risk score.
timeFrame: Screening and week 12.
measure: D:A:D 5-year estimated risk calculator.
timeFrame: Screening and week 12.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clínic i Provincial de Barcelona
name: Esteban Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References: