Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076518
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-01-26
Brief Title:
The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy HAART
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Trial of the Effect of Combination Therapy With Fish Oil Supplement and Fenofibrate on Triglyceride TG Levels in Subjects on Highly Active Antiretroviral Therapy HAART Who Are Not Responding to Either Fish Oil or Fenofibrate Alone
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to determine the effectiveness of fish oil supplements combined with the drug fenofibrate in treating elevated triglyceride levels in people taking anti-HIV drugs The participants in this study will have shown no response to fish oil supplements or fenofibrate alone
Detailed Description:
Although highly active antiretroviral therapy HAART has decreased the morbidity and mortality caused by HIV infection its use has been associated with lipid abnormalities particularly elevations in serum triglycerides Hypertriglyceridemia is a risk factor in the development of cardiovascular and cerebrovascular disease as well as pancreatitis Lipid-lowering drugs called fibrates have been part of the recommended treatment for elevated triglycerides but the response to fibrates is incomplete in a large proportion of people Fish oil capsules containing large amounts of omega-3 fatty acids have been shown to decrease serum triglycerides However fish oil supplements or fibrates alone are often inadequate for treating hypertriglyceridemia in people taking HAART This study will determine whether the combination of the two therapies will lower serum triglycerides in people on HAART more effectively than either therapy alone
This study comprises two steps In Step I participants will be randomly assigned to receive either fish oil supplements or fenofibrate Participants will be evaluated for treatment response at Week 8 Those who have responded to their treatment will remain on their original single agent therapy through Week 18 Those who have not responded to treatment at Week 10 will move on to Step 2 and begin combination therapy with both fenofibrate and fish oil until Week 18 All participants will return at Week 22 for a follow-up visit Except at the Week 10 visit participants will be expected to fast prior to all study visits Participants will remain on their individual HAART regimens for the duration of the study
This study comprises two steps In Step I participants will be randomly assigned to receive either fish oil supplements or fenofibrate Participants will be evaluated for treatment response at Week 8 Those who have responded to their treatment will remain on their original single agent therapy through Week 18 Those who have not responded to treatment at Week 10 will move on to Step 2 and begin combination therapy with both fenofibrate and fish oil until Week 18 All participants will return at Week 22 for a follow-up visit Except at the Week 10 visit participants will be expected to fast prior to all study visits Participants will remain on their individual HAART regimens for the duration of the study
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 |
|---|---|---|---|
| ACTG A5186 | Registry Identifier | DAIDS ES | None |
| 10686 | REGISTRY | None | None |