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

Keywords

ClinConnect Summary

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...

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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.