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Pravastatin for Hyperlipidaemia in HIV.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227500
First Posted: September 28, 2005
Last Update Posted: June 9, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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:
Kirby Institute
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227500


Locations
Australia, New South Wales
St. Vincents Hospital
Sydney, New South Wales, Australia, 2010
Sponsors and Collaborators
Kirby Institute
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

ClinicalTrials.gov Identifier: NCT00227500     History of Changes
Other Study ID Numbers: PRAVA
PRAVA / RO1 HL65953-01
First Submitted: September 27, 2005
First Posted: September 28, 2005
Last Update Posted: June 9, 2006
Last Verified: June 2006

Keywords provided by Kirby Institute:
Hyperlipidaemia
Lipid metabolism
Glucose metabolism
HMG CoA reductase inhibitors
Lipodystrophy
Cardiovascular disease
Treatment Experienced
HIV

Additional relevant MeSH terms:
HIV Infections
Cardiovascular Diseases
Hyperlipidemias
Hyperlipoproteinemias
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors