Pravastatin for Hyperlipidaemia in HIV.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Lipid Metabolism Glucose Metabolism Metabolic Abnormality Lipodystrophy Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pravastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Andrew D Carr, MD

Role: PRINCIPAL_INVESTIGATOR

National Centre in HIV Epidemiology and Clinical Research.

David A Cooper, MD

Role: STUDY_DIRECTOR

National Centre in HIV Epidemiology and Clinical Research.

Locations

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St. Vincents Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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PRAVA / RO1 HL65953-01

Identifier Type: -

Identifier Source: secondary_id

PRAVA