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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

September 27, 2005
June 8, 2006
July 2001
Not Provided
Between-group difference in time weighted change from baseline in fasting serum total cholesterol
The between-group difference in time weighted change from baseline in fasting serum total cholesterol.
Complete list of historical versions of study NCT00227500 on ClinicalTrials.gov Archive Site
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
  • Secondary endpoints included:
  • i. between-group difference in time weighted change from week 4 in fasting serum total cholesterol (start of pravastatin)
  • ii. individual changes in fasting total cholesterol at each measured time point
  • iii. between-group difference in time weighted change from baseline in HDL-cholesterol and triglycerides, change from baseline glucose, insulin
  • iv. between-group difference in change from baseline in total and regional body fat
  • v. between-group difference in change from baseline in endothelial function and peripheral blood markers of cardiovascular risk
Not Provided
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Pravastatin for Hyperlipidaemia in HIV.
A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Lipid Metabolism
  • Glucose Metabolism
  • Metabolic Abnormality
  • Lipodystrophy
  • Cardiovascular Disease
Drug: Pravastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00227500
PRAVA, PRAVA / RO1 HL65953-01
Not Provided
Not Provided
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
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
Kirby Institute
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP