Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC
Methadone hydrochloride
+ Zidovudine
Narcotic-Related Disorders+20
+ Blood-Borne Infections
+ Urogenital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Prior Medication: Allowed: Oral nonabsorbable antifungal agents. 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: Temperature > 101 degrees F. Ascites. Active opportunistic infection. Concurrent Medication: Excluded: Other inducers or inhibitors of hepatic microsomal enzymes. Any chronic systemic medications. Patients with the following symptoms or conditions are excluded: Temperature > 101 degrees F. Ascites. Active opportunistic infection. Prior Medication: Excluded within 72 hours of study entry: All medication except oral nonabsorbable antifungal agents. Excluded within 2 weeks of study entry: Any other experimental drug. Drugs with known nephrotoxic potential or drugs known to cause neutropenia. Rifampin or its derivatives, phenytoin, or barbiturates. Active drug or alcohol abuse.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, United StatesOpen Montefiore Med Ctr / Bronx Municipal Hosp in Google Maps