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
Trial Information
Current as of January 15, 2025
Completed
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
Krown S
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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