Search / Trial NCT00001008

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Substance Withdrawal Syndrome Methadone Opioid Related Disorders Drug Evaluation Drug Interactions Drug Therapy, Combination Administration, Oral Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

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 esse...

Gender

All

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.

Attachments

readout_NCT00001008_2024-07-14.pdf

4.5 MB

NCT00001008_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bronx, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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