Pravastatin for Hyperlipidaemia in HIV.
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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 |
- Between-group difference in time weighted change from baseline in fasting serum total cholesterol
- 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 |
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 |
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| Australia, New South Wales | |
| St. Vincents Hospital | |
| Sydney, New South Wales, Australia, 2010 | |
| 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 May 16, 2013