Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099684
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2004-12-17
Brief Title:
Safety Effectiveness and Tolerability of Ezetimibe Combined With Statins for the Treatment of High Cholesterol in HIV Infected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of the Safety Efficacy and Tolerability of Ezetimibe Zetia in Combination With Statin Therapy for the Treatment of Elevated LDL Cholesterol in HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2012-10
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:
Anti-HIV drugs especially protease inhibitors PIs have been linked to lipid metabolism problems including elevations in low density lipoprotein cholesterol LDL-c triglycerides and total cholesterol Ezetimibe is a lipid-controlling drug statins are part of another class of lipid-lowering drugs popularly prescribed to people with high cholesterol The purpose of this study is to determine the safety effectiveness and tolerability of ezetimibe in combination with statin therapy in adults who are taking anti-HIV drugs and have high cholesterol
Study hypothesis In HIV infected adults ezetimibe in combination with statin therapy will result in significantly lower LDL-c compared to statin therapy alone
Study hypothesis In HIV infected adults ezetimibe in combination with statin therapy will result in significantly lower LDL-c compared to statin therapy alone
Detailed Description:
Lipid metabolism abnormalities are common complications of HIV therapy particularly with PIs Statins and other lipid-lowering agents are often prescribed to control elevated cholesterol levels in both HIV infected and uninfected people However both antiretroviral therapy ART and lipid-lowering drugs may be associated with cardiovascular disease so there is a clear need to find a lipid-lowering drug with low toxicity This study will evaluate the safety efficacy and tolerability of ezetimibe a lipid-controlling agent in combination with ongoing statin therapy in HIV infected people currently on ART
This study will last 28 weeks All participants will be required to continue their current stable statin therapy and ART for the duration of the study
Participants will be randomly assigned to one of two arms Arm 1 participants will receive ezetimibe daily for 12 weeks no treatment for 4 weeks then placebo daily for 12 weeks Arm 2 participants will receive placebo daily for 12 weeks no treatment for 4 weeks and then ezetimibe daily for 12 weeks There will be 9 study visits they will occur at study screening at study entry and every 4 weeks thereafter Clinical assessment and blood collection will occur at all visits Participants will be asked to complete an adherence questionnaire at Weeks 4 12 20 and 28 and will also be encouraged to coenroll in ACTG A5128 Consent for Use of Stored Patient Specimens for Future Testing
This study will last 28 weeks All participants will be required to continue their current stable statin therapy and ART for the duration of the study
Participants will be randomly assigned to one of two arms Arm 1 participants will receive ezetimibe daily for 12 weeks no treatment for 4 weeks then placebo daily for 12 weeks Arm 2 participants will receive placebo daily for 12 weeks no treatment for 4 weeks and then ezetimibe daily for 12 weeks There will be 9 study visits they will occur at study screening at study entry and every 4 weeks thereafter Clinical assessment and blood collection will occur at all visits Participants will be asked to complete an adherence questionnaire at Weeks 4 12 20 and 28 and will also be encouraged to coenroll in ACTG A5128 Consent for Use of Stored Patient Specimens for Future Testing
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