Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT00046267
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2002-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Pilot Study of the Safety, Efficacy, and Tolerability of Extended-Release Niacin (Niaspan) for the Treatment of Elevated Non-HDL Cholesterol and Elevated Triglycerides in HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2006-05
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:
The purpose of this study is to evaluate the safety, efficacy, and tolerability of extended-release niacin (Niaspan) in improving the level of fats in the blood of HIV-infected patients.
Detailed Description:
Lipid disorders are common among patients with HIV and tend to worsen with potent antiretroviral therapy. Lipid-lowering drugs are not always effective, and few data address interactions between antiretroviral drugs and lipid-lowering agents. Additional agents for the treatment of lipid metabolism disorders in HIV-infected patients are needed. Niacin, which is highly effective for similar lipid disorders in the general population, may be effective in treating lipid disorders in patients with HIV.
This 48-week study consists of two steps. In Step 1, patients will begin a lipid-lowering diet and exercise regimen that will continue throughout the study. After 4 weeks on the regimen, patients will enter Step 2 of the study and will begin extended-release niacin therapy. During Step 2, niacin will be dose-escalated every 4 to 6 weeks over a 16-week period. At Weeks 14 and 20, the niacin dose will be determined by blood fat levels. Patients will remain on the dose set at Week 20 for the remainder for the study. If blood tests taken at Week 24 show that blood fat levels have not improved significantly, patients have the option of adding another fat-lowering drug to their therapy.
Patients will visit the clinic at entry and at Weeks 4, 8, 12, 18, 24, 32, 40, and 48. Patients may be asked to come to the clinic at Weeks 14 and 20 to receive additional study drug. Patients must fast for 8 to 12 hours before the screening visit and before each study visit in which blood will be drawn. Blood will be drawn throughout the study for fat, sugar, and insulin tests and for CD4 and CD8 cell counts.
This 48-week study consists of two steps. In Step 1, patients will begin a lipid-lowering diet and exercise regimen that will continue throughout the study. After 4 weeks on the regimen, patients will enter Step 2 of the study and will begin extended-release niacin therapy. During Step 2, niacin will be dose-escalated every 4 to 6 weeks over a 16-week period. At Weeks 14 and 20, the niacin dose will be determined by blood fat levels. Patients will remain on the dose set at Week 20 for the remainder for the study. If blood tests taken at Week 24 show that blood fat levels have not improved significantly, patients have the option of adding another fat-lowering drug to their therapy.
Patients will visit the clinic at entry and at Weeks 4, 8, 12, 18, 24, 32, 40, and 48. Patients may be asked to come to the clinic at Weeks 14 and 20 to receive additional study drug. Patients must fast for 8 to 12 hours before the screening visit and before each study visit in which blood will be drawn. Blood will be drawn throughout the study for fat, sugar, and insulin tests and for CD4 and CD8 cell counts.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: