Pravastatin for Hyperlipidaemia in HIV.

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227500
• Other study ID #: PRAVA
• Secondary ID: PRAVA / RO1 HL65
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2005
• Last updated: June 8, 2006
• Start date: July 2001
• Est. completion date: October 2004

Study information

• Verified date: June 2006
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Glucose Metabolism
• HIV Infections
• Hyperlipidemias
• Lipid Metabolism
• Lipodystrophy
• Metabolic Abnormality

Intervention

Drug:
• Pravastatin

Locations

Country	Name	City	State
Australia	St. Vincents Hospital	Sydney	New South Wales

Sponsors (5)

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

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-group difference in time weighted change from baseline in fasting serum total cholesterol
Secondary	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

External Links

•   National Centre in HIV Epidemiology and Clinical Research Homepage