Search / Trial NCT00000687

Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma

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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Interferon Alfa 2a Drug Evaluation Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine

ClinConnect Summary

In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.

Following evaluation studies, patients who participate in the study receive IFN-A2a and AZ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at a dose of 300 mg once every 4 weeks.
  • AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase of the study.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusions.
  • Patients must have a positive antibody to HIV by any federally licensed ELISA test. All lab tests must be within 7 days of entry into the study.
  • Exclusion Criteria
  • Concurrent Medication:
  • Excluded:
  • Other antiretroviral agents.
  • Immunomodulators.
  • Corticosteroids.
  • Cytotoxic chemotherapy.
  • Aspirin.
  • H2 blockers.
  • Barbiturates and myelosuppressive drugs should be particularly avoided as they may interfere with the metabolism or enhance the toxicities of either zidovudine or interferon alfa-2a.
  • Other experimental medications.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded from the study.
  • Prior Medication:
  • Excluded:
  • Interferon therapy.
  • * Excluded within 30 days of study entry:
  • Immunomodulators.
  • Corticosteroids.
  • Cytotoxic chemotherapeutic agents.
  • * Excluded within 14 days of study entry:
  • Zidovudine (AZT).
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Blood transfusions.
  • Radiation therapy.
  • Patients may not have any of the following diseases or symptoms:
  • Active opportunistic infection associated with AIDS.
  • Significant neurologic disease associated with AIDS, as manifested by motor abnormalities including impaired rapid eye movement or ataxia, motor weakness in the lower extremities, sensory deficit consistent with a peripheral neuropathy, bladder or bowel incontinence.
  • Internal organ involvement with Kaposi's sarcoma, i.e., nonnodal visceral Kaposi's sarcoma, excluding minimal gastrointestinal disease of less than 5 lesions.
  • Tumor-associated edema.
  • Current neoplasm other than Kaposi's sarcoma.
  • Significant cardiac disease, including a recent history of myocardial infarction or significant current cardiac arrhythmias.
  • Active drug or alcohol abuse.

Trial Officials

M Fischl

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Miami, Florida, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

New York, New York, United States

Rochester, New York, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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