Pravastatin for Hyperlipidaemia in HIV.

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Collaborators: Garvan Institute of Medical Research; National Heart, Lung, and Blood Institute (NHLBI); St Vincent's Hospital, Sydney; The University of New South Wales
• Treatments: Pravastatin

Criteria

Inclusion Criteria:

• Provide written informed consent to participate in the trial

• HIV-1 sero-positive

• Male/female >18 years age

• Currently receiving HIV protease inhibitor therapy for > 12 weeks and unlikely to require change in existing regimen during the 16 week study period

• Fasting cholesterol > 6.5 mmol/L (mean of 2 samples collected > 3 days apart)

Exclusion Criteria:

• Any condition which may interfere with ability to comply with study

• Gastrointestinal disorder which may affect drug absorption

• Hypertension or congestive cardiac failure

• Lactic acidemia (serum lactate level >2.2 mmol/L)

• Any serious medical condition which may compromise the patient's safety, including pancreatitis or hepatitis within past 6 months

• Active AIDS defining conditions

• Concurrent therapy with any other lipid lowering agents, oral hypoglycaemics, anabolic steroids or insulin