Methadone Effects on Zidovudine (ZDV, AZT) Disposition

NCT00000800 | Completed Phase 1

• 2 other identifiers: ACTG 26211239
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Methadone; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine

Interventions

Methadone hydrochloride DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator

Study Sites (1)

Yale Univ / New Haven

New Haven, Connecticut, 065102483, United States

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 9715839 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Methadone; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jatlow P

  STUDY CHAIR

• Rainey P

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1998
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)