Pravastatin for Hyperlipidaemia in HIV. - Full Text View

Sponsors and Collaborators:	The National Centre in HIV Epidemiology and Clinical Research The University of New South Wales National Heart, Lung, and Blood Institute (NHLBI) Garvan Institute of Medical Research St Vincent's Hospital, Sydney
Information provided by:	The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier:	NCT00227500

Purpose

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.

Condition	Intervention	Phase
HIV Infections Lipid Metabolism Glucose Metabolism Metabolic Abnormality Lipodystrophy Cardiovascular Disease	Drug: Pravastatin	Phase IV

MedlinePlus related topics: AIDS Cholesterol Statins

Drug Information available for: Pravastatin Pravastatin sodium Dextrose Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:

Between-group difference in time weighted change from baseline in fasting serum total cholesterol

Secondary Outcome Measures:

Includes: between-group difference in time weighted change: from wk 4 in fasting serum total cholesterol as well as from baseline in HDL-cholesterol and triglycerides; in total and regional body fat; in endothelial function

Estimated Enrollment:	40
Study Start Date:	July 2001
Estimated Study Completion Date:	October 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227500

Locations

Australia, New South Wales
St. Vincents Hospital
Sydney, New South Wales, Australia, 2010

Sponsors and Collaborators

The National Centre in HIV Epidemiology and Clinical Research

The University of New South Wales

National Heart, Lung, and Blood Institute (NHLBI)

Garvan Institute of Medical Research

St Vincent's Hospital, Sydney

Investigators

Principal Investigator:	Andrew D Carr, MD	National Centre in HIV Epidemiology and Clinical Research
Study Director:	David A Cooper, MD	National Centre in HIV Epidemiology and Clinical Research

More Information

National Centre in HIV Epidemiology and Clinical Research Homepage This link exits the ClinicalTrials.gov site

Study ID Numbers:	PRAVA, PRAVA / RO1 HL65953-01
Study First Received:	September 27, 2005
Last Updated:	June 8, 2006
ClinicalTrials.gov Identifier:	NCT00227500
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:

Hyperlipidaemia
Lipid metabolism
Glucose metabolism
HMG CoA reductase inhibitors

Lipodystrophy
Cardiovascular disease
Treatment Experienced
HIV

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Hyperlipidemias
Metabolic Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Pravastatin

HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Metabolic disorder
Congenital Abnormalities
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Infection
Pharmacologic Actions
Skin Diseases, Metabolic
Therapeutic Uses
Lentivirus Infections
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009