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

HIV Clinical Trial

— SOS  

Official title:

Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935674
• Other study ID #: SOS
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2013
• Last updated: October 7, 2014
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Hypercholesterolaemia
• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in total cholesterol at 12 weeks.		Baseline and 12 weeks	No
Secondary	Total cholesterol through week 12		12 weeks	No
Secondary	Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)		12 weeks	Yes
Secondary	Quality of life (SF-12)		12 weeks	No
Secondary	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	No
Secondary	Fasting glucose and insulin.		12 weeks	No
Secondary	Framingham cardiovascular risk score.		Screening and week 12.	No
Secondary	D:A:D 5-year estimated risk calculator.		Screening and week 12.	No