Status:

COMPLETED

A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Sarcoma, Kaposi

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and ...

Detailed Description

AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. ...

Eligibility Criteria

Inclusion Criteria

  • Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma.
  • Evidence of HIV infection as manifested by a positive antibody test.

Exclusion Criteria

  • Active drug or alcohol abuse.

Co-existing Condition:

Excluded are patients with:

  • Active opportunistic infections requiring ongoing therapy.
  • Excluded within 90 days of study entry:
  • Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.
  • Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
  • Concurrent neoplasms other than basal cell carcinoma of the skin.
  • Known hypersensitivity to polymycin B or neomycin.

Excluded are patients with:

  • Active opportunistic infections requiring ongoing therapy.
  • Excluded within 90 days of study entry:
  • Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.
  • Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
  • Concurrent neoplasms other than basal cell carcinoma of the skin.
  • Known hypersensitivity to polymycin B or neomycin.

Prior Medication:

Excluded:

  • Interferon.
  • Zidovudine (AZT).
  • Excluded within 30 days of study entry:
  • Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents.
  • Other drugs which can cause neutropenia or significant nephrotoxicity.
  • Rifampin or rifampin derivatives, or systemic anti-infectives.
  • Excluded within 90 days of study entry:
  • Other antiviral agents.
  • A history of Pneumocystis carinii pneumonia (PCP) completed treatment.

Prior Treatment:

Excluded within 30 days of study entry:

  • Radiation therapy.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1990

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT00000725

End Date

February 1 1990

Last Update

November 3 2021

Active Locations (1)

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1

Univ of Miami School of Medicine

Miami, Florida, United States, 331361013