Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Supportive care, Treatment Closed 18 to 60 NIAID NIAID-87-I-32 NCI-V87-0232

Objectives

I.  Evaluate the toxicity and obtain preliminary data on the efficacy of 
combined azidothymidine/alpha interferon in AIDS patients with Kaposi's 
sarcoma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 to 60 years of age with a 
diagnosis of AIDS based on clinical and histologic evidence of Kaposi's 
sarcoma in a previously healthy individual and serologic evidence of prior 
infection with HIV.  Patients should have no evidence of concurrent infection 
requiring systemic therapy.  There may have been no prior chemotherapy, 
corticosteroid therapy, or experimental therapy other than azidothymidine for 
at least 6 weeks prior to study entry; the majority of patients are expected 
to be participating in the NIH Phase II protocol 86-I-74 and will be receiving 
azidothymidine at study entry.  A performance status of 0 or 1 is required, as 
are serum creatinine less than 1.6 mg/dl, serum bilirubin less than 1.5 mg/dl, 
platelets greater than 100,000/cumm, and neutrophils greater than 1,500/cumm.  
Patients must have hemoglobin greater than 10 g/dl prior to drug therapy.

Expected Enrollment

40 patients will be entered.  As of February 1988, an additional 10-15 
patients will be enrolled.

Outline

Nonrandomized study.
2-Drug Combination Antiviral Therapy.  Azidothymidine, AZT, NSC-602670; Alpha 
Interferon, Wellferon (Burroughs Wellcome), IFN-alpha, NSC-339140 (or, if 
Wellferon is unavailable, recombinant alpha-Interferon).

Trial Contact Information

Trial Lead Organizations

National Institute of Allergy and Infectious Diseases

H. Clifford Lane, MD, Protocol chair		Ph: 301-496-1124