Pharmacokinetic interactions of zidovudine and methadone in intravenous drug-using patients with HIV infection.
E L Schwartz, A B Brechbühl, P Kahl...
https://pubmed.ncbi.nlm.nih.gov/1588496/Completed
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2011-03-14
18
Participants Needed
1
Research Sites
N/A
Total Duration
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.
CONDITIONS
A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Inclusion Criteria
Prior Medication:
Allowed:
The study will include 18 patients with AIDS or HIV-related symptomatic illness as defined by the CDC classification group IVa and c2. Of these, 9 methadone recipients will have been maintained on methadone for at least 1 month and will have received a constant daily dose of 30-90 mg of methadone for at least 10 days.
Nine patients will be former intravenous drug abusers.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following symptoms or conditions are excluded:
Prior Medication:
Excluded within 72 hours of study entry:
Active drug or alcohol abuse.
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
E L Schwartz, A B Brechbühl, P Kahl...
https://pubmed.ncbi.nlm.nih.gov/1588496/National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor