Clinical trial NCT00227500: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Garvan Institute of Medical Research
name: St Vincent's Hospital, Sydney
First posted: 2005-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Between-group difference in time weighted change from baseline in fasting serum total cholesterol
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St. Vincents Hospital
state: New South Wales
Study officials:
affiliation: National Centre in HIV Epidemiology and Clinical Research.
name: Andrew D Carr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre in HIV Epidemiology and Clinical Research.
name: David A Cooper, MD
role: STUDY_DIRECTOR
References: