Pravastatin for Hyperlipidaemia in HIV.

This study has been completed.
Sponsor:
Collaborators:
The University of New South Wales
Garvan Institute of Medical Research
St Vincent's Hospital, Sydney
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00227500
First received: September 27, 2005
Last updated: June 8, 2006
Last verified: June 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Kirby Institute
The University of New South Wales
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

Additional Information:
No publications provided

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

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

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

ClinicalTrials.gov processed this record on July 23, 2014