Status:
COMPLETED
Methadone Effects on Zidovudine (ZDV, AZT) Disposition
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Glaxo Wellcome
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 meta...
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 determin...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1998
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00000800
End Date
October 1 1998
Last Update
November 4 2021
Active Locations (1)
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1
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483