Status:
COMPLETED
A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sarcoma, Kaposi
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and ...
Detailed Description
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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1990
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00001113
End Date
March 1 1990
Last Update
November 4 2021
Active Locations (1)
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1
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021