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Pravastatin for Hyperlipidaemia in HIV.

Primary Purpose

HIV Infections, Lipid Metabolism, Glucose Metabolism

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Pravastatin
Sponsored by
Kirby Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Hyperlipidaemia, Lipid metabolism, Glucose metabolism, HMG CoA reductase inhibitors, Lipodystrophy, Cardiovascular disease, Treatment Experienced, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincents Hospital

Outcomes

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

Full Information

First Posted
September 27, 2005
Last Updated
June 8, 2006
Sponsor
Kirby Institute
Collaborators
The University of New South Wales, National Heart, Lung, and Blood Institute (NHLBI), Garvan Institute of Medical Research, St Vincent's Hospital, Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT00227500
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kirby Institute
Collaborators
The University of New South Wales, National Heart, Lung, and Blood Institute (NHLBI), Garvan Institute of Medical Research, St Vincent's Hospital, Sydney

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipid Metabolism, Glucose Metabolism, Metabolic Abnormality, Lipodystrophy, Cardiovascular Disease
Keywords
Hyperlipidaemia, Lipid metabolism, Glucose metabolism, HMG CoA reductase inhibitors, Lipodystrophy, Cardiovascular disease, Treatment Experienced, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pravastatin
Primary Outcome Measure Information:
Title
Between-group difference in time weighted change from baseline in fasting serum total cholesterol
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Carr, MD
Organizational Affiliation
National Centre in HIV Epidemiology and Clinical Research.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Cooper, MD
Organizational Affiliation
National Centre in HIV Epidemiology and Clinical Research.
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincents Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.med.unsw.edu.au/nchecr/
Description
National Centre in HIV Epidemiology and Clinical Research Homepage

Learn more about this trial

Pravastatin for Hyperlipidaemia in HIV.

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