Trials / Completed
CompletedNCT00227500
Pravastatin for Hyperlipidaemia in HIV.
A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Kirby Institute · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- HIV Infections
- Lipid Metabolism
- Glucose Metabolism
- Metabolic Abnormality
- Lipodystrophy
- Cardiovascular Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pravastatin |
Timeline
- Start date
- 2001-07-01
- Completion
- 2004-10-01
- First posted
- 2005-09-28
- Last updated
- 2006-06-09
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT00227500. Inclusion in this directory is not an endorsement.