Pravastatin for Hyperlipidaemia in HIV.

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Brief Title

Pravastatin for Hyperlipidaemia in HIV.

Official Title

A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV

Brief Summary

      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

      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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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

Condition

HIV Infections

Intervention

Pravastatin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

July 2001

Completion Date

October 2004


Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andrew D Carr, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00227500

Organization ID

PRAVA

Secondary IDs

PRAVA / RO1 HL65953-01


Study Sponsor

Kirby Institute

Collaborators

 The University of New South Wales

Study Sponsor

Andrew D Carr, MD, Principal Investigator, National Centre in HIV Epidemiology and Clinical Research.


Verification Date

June 2006