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Methadone Effects on Zidovudine (ZDV, AZT) Disposition

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methadone hydrochloride
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Methadone, Drug Interactions, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale Univ / New Haven

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000800
Brief Title
Methadone Effects on Zidovudine (ZDV, AZT) Disposition
Official Title
Methadone Effects on Zidovudine (ZDV, AZT) Disposition
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Methadone, Drug Interactions, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methadone hydrochloride
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jatlow P
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rainey P
Official's Role
Study Chair
Facility Information:
Facility Name
Yale Univ / New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
065102483
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Jatlow P, Mccance EF, Rainey PM, Trapnell CB, Friedland G. Methadone increases zidovudine exposure in HIV-infected injection drug users (ACTG 262). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:129
Results Reference
background
PubMed Identifier
9715839
Citation
McCance-Katz EF, Rainey PM, Jatlow P, Friedland G. Methadone effects on zidovudine disposition (AIDS Clinical Trials Group 262). J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Aug 15;18(5):435-43. doi: 10.1097/00042560-199808150-00004.
Results Reference
background

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Methadone Effects on Zidovudine (ZDV, AZT) Disposition

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