Rosuvastatin versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults.

Phase 4

Recruiting

• Conditions: Hypercholesterolaemia associated with ritonavir-boosted protease inhibitor therapy in of HIV-infected adults; Infection - Acquired immune deficiency syndrome (AIDS / HIV); Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12612000732886
• Lead Sponsor: St. Vincent's Hospital, Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: 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.

Exclusion Criteria

8.Any statin in the previous 12 weeks
9.Previous statin-induced myopathy or hepatitis
10.History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
11.Concurrent use of:
a). 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)
b). other immunosuppressive or immunomodulating drugs
12.Contra-indication to rosuvastatin therapy:
a). liver transaminases >5 times the upper normal limit
b). creatinine clearance <30 mL/min
c). known myopathy
d). current fibrate therapy
e). known resistance to one or more backbone” ART drugs
13.No potent switch ART drug available to replace the current ritonavir-boosted PI
14.Known intolerance to rosuvastatin or the proposed switch ART drug
15.Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
16.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
17.Unable to complete study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified