A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Methadone hydrochloride Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC |
| Estimated Enrollment: | 18 |
| Primary Completion Date: | March 1991 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00001008 History of Changes |
| Other Study ID Numbers: | ACTG 055 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 11, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Substance Withdrawal Syndrome Methadone Opioid-Related Disorders Drug Evaluation Drug Interactions |
Drug Therapy, Combination Administration, Oral Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections AIDS-Related Complex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Methadone Zidovudine Analgesics, Opioid |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013