A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma

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

Keywords

ClinConnect Summary

AZT has been found to be effective against the effects of HIV in vitro (test tube) and both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is reasonable to assume that a synergism and an enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and effectiveness of AZT in the combination with IFN-A2A is warranted.

Patients are randomized to receive IFN-A or IFN-A2A by intramuscular injection and combined with AZT orally daily for 8 weeks. Two cohorts of 4 patients enter each dose level. Patients do not enter into the nex...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Patient must have a histologically confirmed diagnosis of Kaposi's sarcoma.
• • Positive antibody to HIV confirmed by ELISA or Western blot on the same serum.
• • Exclusion Criteria
• • Active drug or alcohol abuse.
• Co-existing Condition:
• Patients with the following complications are excluded:
• • Active opportunistic infections requiring ongoing therapy.
• • Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90 days prior to study.
• • Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
• • Concurrent neoplasms other than basal cell carcinoma of skin.
• • Known sensitivity to polymycin or neomycin.
• Patients with the following complications are excluded:
• • Active opportunistic infections requiring ongoing therapy.
• • Pneumocystis carinii pneumonia (PCP) unless recovered must be off therapy within 90 days prior to study.
• • Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
• • Concurrent neoplasms other than basal cell carcinoma of skin.
• • Known sensitivity to polymycin or neomycin.
• Prior Medication:
• Excluded:
• • Any prior zidovudine (AZT) or interferon alpha protocol participation.
• * Excluded within 30 days of study entry:
• • Immunomodulating agents.
• • Other drugs that can cause neutropenia or significant nephrotoxicity, or systemic anti-infectives.
• * Excluded within 90 days of study entry:
• • Antiretroviral agents.
• • Treatment of Pneumocystis carinii pneumonia (PCP).
• Prior Treatment:
• Excluded within 30 days of study entry:
• • Radiation therapy.

Trial Officials