Status:
COMPLETED
A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated 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 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. ...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 1990
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00000725
End Date
February 1 1990
Last Update
November 3 2021
Active Locations (1)
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1
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013