Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000800
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Methadone Effects on Zidovudine ZDV AZT Disposition
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Methadone Effects on Zidovudine ZDV AZT Disposition
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:
To determine whether methadone maintenance alters the pharmacokinetics of zidovudine AZT To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists
Injection drug users represent an increasing proportion of HIV-infected persons Since daily methadone maintenance is the major chemical treatment for injection drug abuse it is important to determine the impact of methadone on AZT absorption distribution and elimination
Injection drug users represent an increasing proportion of HIV-infected persons Since daily methadone maintenance is the major chemical treatment for injection drug abuse it is important to determine the impact of methadone on AZT absorption distribution and elimination
Detailed Description:
Injection drug users represent an increasing proportion of HIV-infected persons Since daily methadone maintenance is the major chemical treatment for injection drug abuse it is important to determine the impact of methadone on AZT absorption distribution and elimination
After 6 days of inpatient detoxification with clonidine patients addicted to opiates are randomized to receive either oral or intravenous AZT for the first dose followed by determination of plasma and urine pharmacokinetics On the second day of AZT dosing the alternate form of administration will be used for the first dose On both days all other doses are given orally Patients then begin methadone maintenance in combination with AZT for 7 days of inpatient treatment with further pharmacokinetic sampling After hospitalization for 16 days total patients continue AZTmethadone treatment on an outpatient basis and then 2 months later are readmitted as inpatients for 5 days for further pharmacokinetic sampling Control patients who are not addicted to opiates are hospitalized for 3 days at study entry and are randomized for AZT treatment and pharmacokinetic sampling in the same manner as the first group although they will not receive methadone treatment Control patients are readmitted for 2 days after 1 week of AZT treatment and then again after 59 days of AZT treatment
After 6 days of inpatient detoxification with clonidine patients addicted to opiates are randomized to receive either oral or intravenous AZT for the first dose followed by determination of plasma and urine pharmacokinetics On the second day of AZT dosing the alternate form of administration will be used for the first dose On both days all other doses are given orally Patients then begin methadone maintenance in combination with AZT for 7 days of inpatient treatment with further pharmacokinetic sampling After hospitalization for 16 days total patients continue AZTmethadone treatment on an outpatient basis and then 2 months later are readmitted as inpatients for 5 days for further pharmacokinetic sampling Control patients who are not addicted to opiates are hospitalized for 3 days at study entry and are randomized for AZT treatment and pharmacokinetic sampling in the same manner as the first group although they will not receive methadone treatment Control patients are readmitted for 2 days after 1 week of AZT treatment and then again after 59 days of AZT treatment
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 |
|---|---|---|---|
| 11239 | REGISTRY | DAIDS ES Registry Number | None |