Methadone Effects on Zidovudine (ZDV, AZT) Disposition
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Purpose
To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists.
Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Methadone hydrochloride Drug: Zidovudine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Methadone Effects on Zidovudine (ZDV, AZT) Disposition |
| Estimated Enrollment: | 15 |
| Study Completion Date: | October 1998 |
Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.
After 6 days of inpatient detoxification with clonidine, patients addicted to opiates are randomized to receive either oral or intravenous AZT for the first dose, followed by determination of plasma and urine pharmacokinetics. On the second day of AZT dosing, the alternate form of administration will be used for the first dose. On both days, all other doses are given orally. Patients then begin methadone maintenance in combination with AZT for 7 days of inpatient treatment, with further pharmacokinetic sampling. After hospitalization for 16 days total, patients continue AZT/methadone treatment on an outpatient basis, and then 2 months later are readmitted as inpatients for 5 days for further pharmacokinetic sampling. Control patients who are not addicted to opiates are hospitalized for 3 days at study entry and are randomized for AZT treatment and pharmacokinetic sampling in the same manner as the first group, although they will not receive methadone treatment. Control patients are readmitted for 2 days after 1 week of AZT treatment and then again after 59 days of AZT treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- Documented HIV infection.
- CD4 count 100 - 500 cells/mm3.
- No active opportunistic infection or wasting syndrome.
- Opiate addiction or prior enrollment in a methadone treatment program (methadone recipients only).
- Admission to General Clinical Research Center at Yale-New Haven Hospital for clonidine detoxification (methadone recipients only).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Inadequate IV access.
- Benzodiazepine abuse.
Concurrent Medication:
Excluded:
- Amiodarone.
- Anesthetics, general.
- Azithromycin.
- Barbiturates.
- Carbamazepine.
- Cimetidine.
- Ciprofloxacin.
- Clarithromycin.
- Dexamethasone.
- Disulfiram.
- Erythromycin.
- Fluoroquinolones.
- Fluoxetine.
- Gestodene.
- Hydrochlorothiazide.
- Hypoglycemics, oral.
- Isoniazid.
- Itraconazole.
- Ketoconazole.
- Levomepromazine.
- MAO inhibitors.
- Methoxsalen.
- Nafcillin.
- Narcotic analgesics.
- Naringenin.
- Norethindrone.
- Omeprazole.
- Pentazocine.
- Phenothiazines.
- Phenytoin.
- Quinidine.
- Ranitidine.
- Rifabutin.
- Rifampin.
- Sedative Hypnotics.
- Sulfaphenazole.
- Tranquilizers (except at discretion of investigator and protocol chair).
- Tricyclic antidepressants.
- Troleandomycin.
- Warfarin.
Prior Medication:
Excluded within 4 weeks prior to study entry:
- Rifampin or its derivatives.
- Phenytoin.
- Barbiturates.
- Cimetidine.
- Other drugs known to induce or inhibit hepatic microsomal enzymes.
Excluded within 14 days prior to study entry:
- Any other experimental drug.
- Drugs with known nephrotoxic potential.
Excluded within 72 hours prior to study entry:
- Amiodarone.
- Anesthetics, general.
- Azithromycin.
- Carbamazepine.
- Ciprofloxacin.
- Clarithromycin.
- Dexamethasone.
- Disulfiram.
- Erythromycin.
- Fluoroquinolones.
- Fluoxetine.
- Gestodene.
- Hydrochlorothiazide.
- Hypoglycemics, oral.
- Isoniazid.
- Itraconazole.
- Ketoconazole.
- Levomepromazine.
- MAO inhibitors.
- Methoxsalen.
- Nafcillin.
- Narcotic analgesics.
- Naringenin.
- Norethindrone.
- Omeprazole.
- Pentazocine.
- Phenothiazines.
- Quinidine.
- Ranitidine.
- Rifabutin.
- Sedative Hypnotics.
- Sulfaphenazole.
- Tranquilizers (except at discretion of investigator and protocol chair).
- Tricyclic antidepressants.
- Troleandomycin.
- Warfarin.
Continued active drug or alcohol abuse or dependence that would decrease the probability of study completion.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000800 History of Changes |
| Other Study ID Numbers: | ACTG 262, 11239 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Methadone Drug Interactions Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus 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 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013