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

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. 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.

Key facts

Study ID

NCT00000687

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

1993-07-01

Last updated by the study team

2021-11-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Washington U CRS — St Louis, Missouri, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Case CRS — Cleveland, Ohio, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• Pitt CRS — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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