Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227500
Status:
COMPLETED
Last Update Posted:
2006-06-09
First Post:
2005-09-27
Brief Title:
Pravastatin for Hyperlipidaemia in HIV
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
A Randomised Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRAVA RO1 HL65953-01 | None | None | None |