A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Methadone; Zidovudine

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.