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

Sponsor

Juan A. Arnaiz (Other)

Overall Status

Completed

CT.gov ID

NCT01935674

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Hypercholesterolaemia	Drug: Switch ritonavir-boosted PI Drug: Continue Ritonavir-boosted PI+Rosuvastatin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Percentage change from baseline in total cholesterol at 12 weeks. [Baseline and 12 weeks]

Secondary Outcome Measures

Total cholesterol through week 12 [12 weeks]
Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy) [12 weeks]
Quality of life (SF-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.]
D:A:D 5-year estimated risk calculator. [Screening and week 12.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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