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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001008 |
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: | Treatment, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC |
| Estimated Enrollment: | 18 |
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:
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.
Contacts and Locations More Information
| Study ID Numbers: | ACTG 055 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001008 |
| Health Authority: | United States: Federal Government |
|
Substance Withdrawal Syndrome Methadone Opioid-Related Disorders Drug Evaluation Drug Interactions |
Drug Therapy, Combination Administration, Oral Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
|
Sexually Transmitted Diseases, Viral Substance Withdrawal Syndrome Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Opioid-Related Disorders Immunologic Deficiency Syndromes Naphazoline Virus Diseases |
Oxymetazoline Methadone Guaifenesin HIV Infections Phenylephrine Sexually Transmitted Diseases Phenylpropanolamine Retroviridae Infections |
|
Antimetabolites Respiratory System Agents Anti-Infective Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics Analgesics, Opioid |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Central Nervous System Depressants Narcotics Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Lentivirus Infections Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents |
