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

NCT ID: NCT01935674

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-09-30

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

Conditions

HIV; Hypercholesterolaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Switch ritonavir-boosted PI

Intervention Type: DRUG

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).

Group Type: EXPERIMENTAL

Continue Ritonavir-boosted PI+Rosuvastatin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Continue Ritonavir-boosted PI+Rosuvastatin

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juan A. Arnaiz

OTHER

Sponsor Role: lead

Responsible Party

Juan A. Arnaiz

Project manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Esteban Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clinic of Barcelona

Barcelona, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/26987376/

Rosuvastatin vs. protease inhibitor switching for hypercholesterolaemia: a randomized trial

Other Identifiers

SOS

Identifier Type: -

Identifier Source: org_study_id