Completed

Phase 1
Age: 18Years +
All Genders
ID00000800

Methadone Effects on Zidovudine (ZDV, AZT) Disposition

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

G

Glaxo Wellcome

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Methadone Effects on Zidovudine (ZDV, AZT) Disposition

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

Yale Univ / New Haven

New Haven, Connecticut, United States, 065102483

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial