Pravastatin for Hyperlipidaemia in HIV.

Kirby Institute

Status and phase

Completed

Phase 4

Conditions

Lipid Metabolism

Lipodystrophy

Glucose Metabolism

Metabolic Abnormality

HIV Infections

Cardiovascular Disease

Treatments

Drug: Pravastatin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00227500

PRAVA

PRAVA / RO1 HL65953-01

Details and patient eligibility

About

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.

Full description

High serum cholesterol concentrations are commonly seen in HIV-infected patients treated with some protease inhibitor medications as part of long-term antiretroviral therapy for HIV. There is concern that these elevations in cholesterol may negatively impact on long-term risk of cardiovascular disease in this patient population. Pravastatin, a HMG-CoA reductase inhibitor, is commonly used to treat hypercholesterolaemia in the general population. We aim to examine the effect of 12 weeks therapy with 40mg pravastatin daily in conjunction with dietary advice in HIV-infected patients with elevated serum cholesterol on continued protease inhibitor therapy.

After 4 weeks of dietary advice, patients will be randomised to receive either pravastatin or placebo for 12 weeks. Assessments include fasting lipid and glycaemic parameters, measures of body composition and HIV disease, and surrogate markers for cardiovascular disease.

Although previous small studies of pravastatin in this field have been performed, none has done so in a randomised placebo controlled trial taking into account all the relevant measures.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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