Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001008
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC
Status:
COMPLETED
Status Verified Date:
1991-08
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 if methadone treatment will affect the blood levels of zidovudine AZT in patients with AIDS or AIDS-related complex ARC who are receiving oral AZT and methadone therapy In addition the blood levels of methadone both before and during AZT treatment will be studied and patients receiving daily oral methadone treatment will be evaluated for signs of narcotic withdrawal during treatment with AZT
The number of deaths due to AIDS in high-risk populations continues to increase Nationwide approximately 25 percent of AIDS patients are intravenous IV drug abusers and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse The major chemical treatment for IV drug abuse is daily methadone maintenance therapy and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT Therefore the study of potential drug interactions is essential
The number of deaths due to AIDS in high-risk populations continues to increase Nationwide approximately 25 percent of AIDS patients are intravenous IV drug abusers and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse The major chemical treatment for IV drug abuse is daily methadone maintenance therapy and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT Therefore the study of potential drug interactions is essential
Detailed Description:
The number of deaths due to AIDS in high-risk populations continues to increase Nationwide approximately 25 percent of AIDS patients are intravenous IV drug abusers and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse The major chemical treatment for IV drug abuse is daily methadone maintenance therapy and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT Therefore the study of potential drug interactions is essential
The 18 patients are patients with AIDS or ARC Nine are control patients who are not receiving methadone and are not IV drug abusers Nine are former IV drug abusers who have been maintained on methadone for at least 6 months and who have been receiving a constant daily dose of methadone for at least 1 month Plasma and urine levels of methadone are determined over a 4 hour period The dose of AZT For the pharmacokinetic study of AZT plasma and urine samples are taken after oral dose of AZT and an intravenous dose of AZT in the control and methadone groups
The 18 patients are patients with AIDS or ARC Nine are control patients who are not receiving methadone and are not IV drug abusers Nine are former IV drug abusers who have been maintained on methadone for at least 6 months and who have been receiving a constant daily dose of methadone for at least 1 month Plasma and urine levels of methadone are determined over a 4 hour period The dose of AZT For the pharmacokinetic study of AZT plasma and urine samples are taken after oral dose of AZT and an intravenous dose of AZT in the control and methadone groups
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?: