Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039975
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-06-18
Brief Title:
Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
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 HIV Protease Inhibitors and Calcium Channel Blockers
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:
Diltiazem CD and amlodipine are drugs used to treat heart disease and high blood pressure The purpose of this study is to find out if these drugs interact with the anti-HIV drugs indinavir and ritonavir The study will also look at the safety of taking the study drugs together
Heart disease and high blood pressure are major health concerns for people with HIV Standard treatment for these illnesses often includes calcium channel blockers CCBs There is a potential for significant drug interactions between CCBs and HIV protease inhibitors PIs that may influence the dosing monitoring and choosing of CCBs and PIs when used in people infected with HIV This study will examine the drug interactions between 2 commonly used CCBs and the PI combination indinavir and ritonavir IDVRTV This information should help doctors choose the appropriate treatment for high blood pressure or heart disease in people taking PIs
Heart disease and high blood pressure are major health concerns for people with HIV Standard treatment for these illnesses often includes calcium channel blockers CCBs There is a potential for significant drug interactions between CCBs and HIV protease inhibitors PIs that may influence the dosing monitoring and choosing of CCBs and PIs when used in people infected with HIV This study will examine the drug interactions between 2 commonly used CCBs and the PI combination indinavir and ritonavir IDVRTV This information should help doctors choose the appropriate treatment for high blood pressure or heart disease in people taking PIs
Detailed Description:
Ischemic cardiovascular disease and hypertension occur in persons with HIV infection and the incidence and prevalence may increase over time as the infected population ages Standard pharmacologic interventions for these illnesses often include calcium channel blockers CCBs Many of the calcium channel blockers are metabolized by cytochrome P450 3A4 CYP 3A4 which is inhibited by some protease inhibitors PIs Thus there is potential for clinically significant interactions between CCBs and PIs The presence of significant drug-drug interactions may influence the dosing monitoring and choosing of CCBs andor PIs when used in persons with HIV infection Because of the potential concomitant use of CCBs with the PI combination IDVRTV this study will evaluate bi-directional drug-drug interactions between 2 commonly used CCBs and IDVRTV This information should assist clinicians in choosing the appropriate CCBs to treat hypertension or cardiovascular disease in persons taking PIs
Patients are randomized to 1 of the following 2 arms
Arm A diltiazem CD interaction with IDV and RTV Arm B amlodipine interaction with IDV and RTV From Days 1 to 7 patients take diltiazem CD Arm A or amlodipine Arm B Plasma is collected for PK over a 24-hour period beginning on Day 7 From Days 8 to 19 patients stop taking their assigned CCB and take IDV and RTV Plasma is collected for PK over a 12-hour period on Day 19 From Days 20 to 26 patients continue to take IDV and RTV and add diltiazem CD Arm A or amlodipine Arm B Patients stop all 3 drugs after the last dose on Day 26 Plasma is collected for PK for a 24-hour period beginning on Day 26 Blood work liver and kidney function tests urinalysis and an electrocardiogram EKG are performed at some visits
Patients are randomized to 1 of the following 2 arms
Arm A diltiazem CD interaction with IDV and RTV Arm B amlodipine interaction with IDV and RTV From Days 1 to 7 patients take diltiazem CD Arm A or amlodipine Arm B Plasma is collected for PK over a 24-hour period beginning on Day 7 From Days 8 to 19 patients stop taking their assigned CCB and take IDV and RTV Plasma is collected for PK over a 12-hour period on Day 19 From Days 20 to 26 patients continue to take IDV and RTV and add diltiazem CD Arm A or amlodipine Arm B Patients stop all 3 drugs after the last dose on Day 26 Plasma is collected for PK for a 24-hour period beginning on Day 26 Blood work liver and kidney function tests urinalysis and an electrocardiogram EKG are performed at some visits
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 A5159 | Registry Identifier | DAIDS ES | None |
| 10959 | REGISTRY | None | None |
| ACTG A5159 | None | None | None |