Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

NA

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, ...

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 i...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT00001008

Last Update

March 14 2011

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, United States, 10467