Search / Trial NCT00000725

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

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

Interferon Alfa 2a Sarcoma, Kaposi Dose Response Relationship, Drug Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine Interferon Type I

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. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted. Patients are randomized to receive IFN-A or IFN-A2A (given by intramuscular injection) and combined with AZT (taken orally) daily for 8 weeks. Study stops when maximum tol...

Gender

All

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.

Attachments

readout_NCT00000725_2024-07-14.pdf

4.5 MB

NCT00000725_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

Miami, Florida, 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

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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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