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

Phase 4

Completed

• Conditions: HIV; Hypercholesterolaemia
• Interventions: Drug: Switch ritonavir-boosted PI; Drug: Continue Ritonavir-boosted PI+Rosuvastatin

• Registration Number: NCT01935674
• Lead Sponsor: Juan A. Arnaiz

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

Study Timeline

• Study First Submitted: 2013-03-19
• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switch ritonavir-boosted PI	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.
Continue ritonavir-boosted PI+Rosuvastatin	Continue Ritonavir-boosted PI+Rosuvastatin	Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline in total cholesterol at 12 weeks.	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life (SF-12)	12 weeks
D:A:D 5-year estimated risk calculator.	Screening and week 12.
Total cholesterol through week 12	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	12 weeks
Fasting glucose and insulin.	12 weeks
Framingham cardiovascular risk score.	Screening and week 12.
Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)	12 weeks

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain