Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000941
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study on Possible Interactions Between Protease Inhibitors Anti-HIV Drugs and Drugs Which Lower the Level of Fat in Your Blood
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Potential Pharmacokinetic Interactions Between Protease Inhibitors and Lipid Lowering Agents
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 find out whether taking protease inhibitors anti-HIV drugs together with lipid-lowering drugs drugs which lower the amount of fat in the blood has an effect on the level of drugs found in the blood compared to when these drugs are taken separately The three protease inhibitors given in this study are ritonavir saquinavir and nelfinavir The lipid-lowering drugs given are pravastatin simvastatin and atorvastatin
Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients Recently however serious side effects involving how the body uses fat have been reported in people taking protease inhibitors Examples of these side effects are redistribution of body fat and development of diabetes People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal which can cause heart problems It is hoped that giving lipid-lowering drugs can help prevent serious heart problems First however it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together
Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients Recently however serious side effects involving how the body uses fat have been reported in people taking protease inhibitors Examples of these side effects are redistribution of body fat and development of diabetes People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal which can cause heart problems It is hoped that giving lipid-lowering drugs can help prevent serious heart problems First however it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together
Detailed Description:
Potent antiretroviral therapy has become the standard of care for persons with HIV infection and AIDS Recently however a number of complications have emerged with the widespread use of protease inhibitor PI-based regimens including hyperlipidemia hypertriglyceridemia diabetes mellitus and lipodystrophy Concern over the possibility of premature myocardial infarction has led health care providers and patients to consider treating these lipid metabolism disorders Statin compounds have beneficial effects as lipid-lowering agents and thereby reduce the risk of cardiovascular complications Statin compounds such as pravastatin simvastatin and atorvastatin are increasingly being prescribed in persons taking PI-based potent antiretroviral therapy It is important to determine whether there are significant drug-drug interactions between the statin compounds and PIs
Fourteen healthy participants for each cohort of Arm A are stabilized on a fixed regimen of pravastatin Arm A1 simvastatin Arm A2 or atorvastatin Arm A3 for 4 days A baseline pharmacokinetic PK evaluation is completed on Day 4 Pravastatin or simvastatin or atorvastatin dosing stops following the Day 4 dose and PK evaluation On Day 5 a ritonavir and saquinavir combination regimen is initiated and continued through Day 18 of the study Pravastatin or simvastatin or atorvastatin dosing resumes on Day 15 and continues through Day 18 A repeat PK evaluation of pravastatin or simvastatin or atorvastatin in the context of combination therapy is carried out on Day 18
Fourteen healthy participants are assigned to Arm B these participants begin a 2-week regimen of nelfinavir On Day 14 a baseline PK profile of nelfinavir and its M8 metabolite is carried out Pravastatin is then added to the regimen for Days 15 to 18 On Day 18 a repeat PK evaluation of nelfinavir and the M8 metabolite is carried out in the context of combination therapy
Fourteen healthy participants for each cohort of Arm A are stabilized on a fixed regimen of pravastatin Arm A1 simvastatin Arm A2 or atorvastatin Arm A3 for 4 days A baseline pharmacokinetic PK evaluation is completed on Day 4 Pravastatin or simvastatin or atorvastatin dosing stops following the Day 4 dose and PK evaluation On Day 5 a ritonavir and saquinavir combination regimen is initiated and continued through Day 18 of the study Pravastatin or simvastatin or atorvastatin dosing resumes on Day 15 and continues through Day 18 A repeat PK evaluation of pravastatin or simvastatin or atorvastatin in the context of combination therapy is carried out on Day 18
Fourteen healthy participants are assigned to Arm B these participants begin a 2-week regimen of nelfinavir On Day 14 a baseline PK profile of nelfinavir and its M8 metabolite is carried out Pravastatin is then added to the regimen for Days 15 to 18 On Day 18 a repeat PK evaluation of nelfinavir and the M8 metabolite is carried out in the context of combination therapy
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10891 | REGISTRY | None | None |
| ACTG A5047 | Registry Identifier | DAIDS ES | None |