Pravastatin for Hyperlipidaemia in HIV.
A Randomised, Double-blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients with HIV
The University of New South Wales
40 participants
Jul 12, 2002
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Provide written informed consent to participate in the trial - HIV-1 sero-positive - 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 Criteria1
- 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 patients 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.
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Interventions
This study is a randomised, placebo-controlled study of the effect of 12 weeks 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.
Locations(1)
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ACTRN12605000663651