A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001008
First received: November 2, 1999
Last updated: March 11, 2011
Last verified: August 1991

November 2, 1999
March 11, 2011
Not Provided
March 1991   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00001008 on ClinicalTrials.gov Archive Site
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A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC)
Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC

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.

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.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: Methadone hydrochloride
  • Drug: Zidovudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Not Provided
March 1991   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001008
ACTG 055
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: G Friedland
National Institute of Allergy and Infectious Diseases (NIAID)
August 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP