Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006412
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-10-13
Brief Title:
Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Multicenter Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities
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 compare the safety and effectiveness of fenofibrate and pravastatin in treating HIV-positive patients who have abnormal levels of fat lipids in the blood
Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem The drugs used in this study are known to reduce certain lipids but little is known about their safety and effectiveness This study will see if one of the drugs is safer and more effective than the other or if combining the drugs is the safest and most effective way to lower lipids This study has been changed On June 26 2001 this study was reviewed by the Data and Safety Monitoring Board DSMB The DSMB is an independent board monitoring the progress of the study The review showed that neither pravastatin nor fenofibrate alone were effective in reaching all the cholesterol and triglyceride goals There were no safety concerns It is not known if the combination of fenofibrate and pravastatin is effective and safe Therefore it is important to continue this study
Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem The drugs used in this study are known to reduce certain lipids but little is known about their safety and effectiveness This study will see if one of the drugs is safer and more effective than the other or if combining the drugs is the safest and most effective way to lower lipids This study has been changed On June 26 2001 this study was reviewed by the Data and Safety Monitoring Board DSMB The DSMB is an independent board monitoring the progress of the study The review showed that neither pravastatin nor fenofibrate alone were effective in reaching all the cholesterol and triglyceride goals There were no safety concerns It is not known if the combination of fenofibrate and pravastatin is effective and safe Therefore it is important to continue this study
Detailed Description:
Lipid disorders associated with HIV infection and antiretroviral therapy are of growing concern There is little information available on the safety and efficacy of statins or fibrates in the treatment of HIV-associated hyperlipidemias Fenofibrate and pravastatin both are able to reduce low-density lipoproteins LDL and triglycerides TG but it is unclear whether one therapy will be more effective than the other or if combination therapy will be needed to achieve desirable reductions in both LDL and TG AS PER AMENDMENT 121301 The NIAID HIV Therapeutic Trials Data and Safety Monitoring Board DSMB met June 26 2001 to review the interim results The interim monitoring plan for this study states that accrual into either single-agent therapy arm should stop if the response rate failed to meet a pre-specified minimum at the time of interim review The DSMB found that this stopping criterion was met for each single-therapy arm The DSMB recommended that patients currently on single-agent therapy be offered the opportunity to initiate dual-agent therapy regardless of time on study There were no safety concerns
Patients are randomized to either Arm A or Arm B and stratified by gender TG level and number of cardiovascular risk factors Patients add daily fenofibrate Arm A or pravastatin Arm B to their antiretroviral therapy for 48 weeks Evaluations at Week 12 determine LDL TG and high-density lipid HDL levels Patients who achieve clinical goals for these levels stay on the drug for the rest of the study Patients who do not achieve the goals by Week 12 receive a combination of pravastatin and fenofibrate for the rest of the study At regular clinic visits patients have physical exams and are questioned about their medications diet and exercise Blood samples are drawn for clinical evaluations including lipid profiles and HIV-1 RNA monitoring AS PER AMENDMENT 121301 On June 26 2001 the DSMB reviewed interim results and determined that the response rates for both arms met the stopping rule for futility As a result all patients who were currently on single-agent therapy were offered the opportunity to initiate dual-agent therapy regardless of time on study No additional accrual was sought however exceptions were made for patients who were in screening at the time of the DSMB review These patients were given the option of starting single- or dual-agent therapy The DSMB recommended that all patients on dual-agent therapy be followed for 32 weeks to obtain additional safety and efficacy data Further endpoints will be analyzed after Week 12 of single-agent therapy or Week 32 of dual-agent therapy
Patients are randomized to either Arm A or Arm B and stratified by gender TG level and number of cardiovascular risk factors Patients add daily fenofibrate Arm A or pravastatin Arm B to their antiretroviral therapy for 48 weeks Evaluations at Week 12 determine LDL TG and high-density lipid HDL levels Patients who achieve clinical goals for these levels stay on the drug for the rest of the study Patients who do not achieve the goals by Week 12 receive a combination of pravastatin and fenofibrate for the rest of the study At regular clinic visits patients have physical exams and are questioned about their medications diet and exercise Blood samples are drawn for clinical evaluations including lipid profiles and HIV-1 RNA monitoring AS PER AMENDMENT 121301 On June 26 2001 the DSMB reviewed interim results and determined that the response rates for both arms met the stopping rule for futility As a result all patients who were currently on single-agent therapy were offered the opportunity to initiate dual-agent therapy regardless of time on study No additional accrual was sought however exceptions were made for patients who were in screening at the time of the DSMB review These patients were given the option of starting single- or dual-agent therapy The DSMB recommended that all patients on dual-agent therapy be followed for 32 weeks to obtain additional safety and efficacy data Further endpoints will be analyzed after Week 12 of single-agent therapy or Week 32 of dual-agent therapy
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 |
|---|---|---|---|
| AACTG A5087 | Registry Identifier | DAIDS ES | None |
| 10917 | REGISTRY | None | None |
| ACTG A5087 | None | None | None |