Treatment with Rosuvastatin versus switching PI (protease inhibitor) in patients HIV with high cholesterol levels.

• Conditions: HIV AND HYPERCHOLESTEROLAEMIA; MedDRA version: 16.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-000486-37-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-12
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.HIV-positive status
2.Adults (?18 years of age)
3.Stable and well-tolerated combination ART including a ritonavir-boosted PI for the previous 6 months
4.HIV RNA <50 copies/mL for at least the preceding 3 months
5.Fasting total cholesterol ?5.5 mmol/L (>213 mg/dL)
6.Framingham risk score ?8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
7.Provision of written, informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Any statin in the previous 12 weeks
2.Previous statin-induced myopathy or hepatitis
3.History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
4.Concurrent use of:
?oral corticosteroids use other than for replacement therapy (ie. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
?other immunosuppressive or immunomodulating drugs
5.Contra-indication 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
6.No potent switch ART drug available to replace the current ritonavir-boosted PI
7.Known intolerance to rosuvastatin or the proposed switch ART drug
8.Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
9.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
10.Unable to complete study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified