Back to resultsA Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methadone hydrochloride
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Substance Withdrawal Syndrome, Methadone, Opioid-Related Disorders, Drug Evaluation, Drug Interactions, Drug Therapy, Combination, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Prior Medication: Allowed: Oral nonabsorbable antifungal agents. The study will include 18 patients with AIDS or HIV-related symptomatic illness as defined by the CDC classification group IVa and c2. Of these, 9 methadone recipients will have been maintained on methadone for at least 1 month and will have received a constant daily dose of 30-90 mg of methadone for at least 10 days. Nine patients will be former intravenous drug abusers. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Temperature > 101 degrees F. Ascites. Active opportunistic infection. Concurrent Medication: Excluded: Other inducers or inhibitors of hepatic microsomal enzymes. Any chronic systemic medications. Patients with the following symptoms or conditions are excluded: Temperature > 101 degrees F. Ascites. Active opportunistic infection. Prior Medication: Excluded within 72 hours of study entry: All medication except oral nonabsorbable antifungal agents. Excluded within 2 weeks of study entry: Any other experimental drug. Drugs with known nephrotoxic potential or drugs known to cause neutropenia. Rifampin or its derivatives, phenytoin, or barbiturates. Active drug or alcohol abuse.
Sites / Locations
- Montefiore Med Ctr / Bronx Municipal Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001008
First Posted
November 2, 1999
Last Updated
March 11, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001008
Brief Title
A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)
Official Title
Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC
Study Type
Interventional
2. Study Status
Record Verification Date
August 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
March 1991 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone therapy. In addition, the blood levels of methadone both before and during AZT treatment will be studied, and patients receiving daily oral methadone treatment will be evaluated for signs of narcotic withdrawal during treatment with AZT.
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.
Detailed Description
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.
The 18 patients are patients with AIDS or ARC. Nine are control patients who are not receiving methadone and are not IV drug abusers. Nine are former IV drug abusers who have been maintained on methadone for at least 6 months and who have been receiving a constant daily dose of methadone for at least 1 month. Plasma and urine levels of methadone are determined over a 4 hour period. The dose of AZT: For the pharmacokinetic study of AZT, plasma and urine samples are taken after oral dose of AZT and an intravenous dose of AZT in the control and methadone groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Substance Withdrawal Syndrome, Methadone, Opioid-Related Disorders, Drug Evaluation, Drug Interactions, Drug Therapy, Combination, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
18 (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
Prior Medication:
Allowed:
Oral nonabsorbable antifungal agents.
The study will include 18 patients with AIDS or HIV-related symptomatic illness as defined by the CDC classification group IVa and c2. Of these, 9 methadone recipients will have been maintained on methadone for at least 1 month and will have received a constant daily dose of 30-90 mg of methadone for at least 10 days.
Nine patients will be former intravenous drug abusers.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Temperature > 101 degrees F.
Ascites.
Active opportunistic infection.
Concurrent Medication:
Excluded:
Other inducers or inhibitors of hepatic microsomal enzymes.
Any chronic systemic medications.
Patients with the following symptoms or conditions are excluded:
Temperature > 101 degrees F.
Ascites.
Active opportunistic infection.
Prior Medication:
Excluded within 72 hours of study entry:
All medication except oral nonabsorbable antifungal agents.
Excluded within 2 weeks of study entry:
Any other experimental drug.
Drugs with known nephrotoxic potential or drugs known to cause neutropenia.
Rifampin or its derivatives, phenytoin, or barbiturates.
Active drug or alcohol abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G Friedland
Official's Role
Study Chair
Facility Information:
Facility Name
Montefiore Med Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Schwartz EL, Brechbuhl AB, Kahl P, Miller MH, Selwyn PA, Friedland GH. Altered pharmacokinetics of zidovudine in former IV drug-using patients receiving methadone. Int Conf AIDS. 1990 Jun 20-23;6(3):194 (abstract no SB432)
Results Reference
background
PubMed Identifier
1588496
Citation
Schwartz EL, Brechbuhl AB, Kahl P, Miller MA, Selwyn PA, Friedland GH. Pharmacokinetic interactions of zidovudine and methadone in intravenous drug-using patients with HIV infection. J Acquir Immune Defic Syndr (1988). 1992;5(6):619-26.
Results Reference
background
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A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)
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