Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000906
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects
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 see if it is safe to combine methadone with two HIV protease inhibitors PIs ritonavir RTV and saquinavir SQV in HIV-infected patients not currently taking PIs This study will measure the interactions between methadone and the PIs
Methadone is used treat addicts and to treat severe pain In order to find the safest way to use methadone with PIs it is important to evaluate how they interact
Methadone is used treat addicts and to treat severe pain In order to find the safest way to use methadone with PIs it is important to evaluate how they interact
Detailed Description:
Methadone is extensively used in the maintenance treatment of addicts and in the management of severe pain In order to use methadone with HIV protease inhibitors correctly it is important to evaluate and quantify interactions between the protease inhibitors and methadone
Patients receive their usual daily dose of methadone followed with ritonavir and saquinavir respectively twice a day Patients are evaluated on Day 4 for safety and tolerance and their ritonavir dose is increased On Day 8 patients are evaluated for a steady-state level of methadone After 2 weeks of the protease inhibitor therapy they return for methadone pharmacokinetic sampling at Day 15 over 24 hours Both protease inhibitors and methadone are administered on Day 15 on an inpatient basis On Day 30 patients are assessed for safety and tolerance
Patients receive their usual daily dose of methadone followed with ritonavir and saquinavir respectively twice a day Patients are evaluated on Day 4 for safety and tolerance and their ritonavir dose is increased On Day 8 patients are evaluated for a steady-state level of methadone After 2 weeks of the protease inhibitor therapy they return for methadone pharmacokinetic sampling at Day 15 over 24 hours Both protease inhibitors and methadone are administered on Day 15 on an inpatient basis On Day 30 patients are assessed for safety and tolerance
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 |
|---|---|---|---|
| 11357 | REGISTRY | DAIDS ES | None |