Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma

NCT00000695 | Completed Phase 1

• 2 other identifiers: ACTG 05711031
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.

Conditions

Sarcoma, Kaposi; HIV Infections

Keywords

Drug Evaluation; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Zidovudine; Interferon Type I

Interventions

Interferon beta-1b DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Treatment:
• Allowed:
• Local radiotherapy or laser therapy to cosmetically apparent Kaposi's lesions, provided the dose to any one lesion does not exceed 3000 gray and the total surface area of all lesions treated does not exceed 10 cm2 during the course of the trial.
• Patients must demonstrate the following clinical and laboratory findings:
• Positive for HIV by federally licensed ELISA test.
• Acceptable bone marrow function.
• Acceptable renal function.
• Acceptable hepatic function.

You may not qualify if:

• Concurrent Medication:
• Excluded:
• Other potentially antiretroviral compounds.
• Patients will be excluded from the study for the following reasons:
• Concurrent, active opportunistic infections requiring therapy.
• Extensive Kaposi's sarcoma with more than 100 cutaneous lesions, requiring systemic chemotherapy, prior treatment with more than one chemotherapy regimen, excluding intralesional therapy, or symptomatic visceral Kaposi's sarcoma.
• Evidence of clinically significant cardiac dysfunction (New York Heart Association grade III or IV).
• History of malignant neoplasms other than nonmelanomatous skin cancer or cancer in situ of the cervix.
• Proteinuria of 2+ or greater and/or 24-hour urine protein of greater than 1.
• Prior Medication:
• Excluded:
• More than one chemotherapy regimen for Kaposi's sarcoma.
• Any interferon preparation or zidovudine (AZT).
• Excluded within 30 days of study entry:
• Other immunomodifiers.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

USC School of Medicine / Norris Cancer Hosp

Los Angeles, California, 90033, United States

Location

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Stavermann T, Bauer G, Ruess A. Recombinant interferon-beta in the therapy of advanced AIDS-related Kaposi's sarcoma. Int Conf AIDS. 1993 Jun 6-11;9(1):402 (abstract no PO-B12-1600)

  BACKGROUND

• Miles S, Levine A, Feldstein M, Carden J, Cabriallas S, Marcus S, Mitsuyasu R, Gill P. Open-label phase I study of combination therapy with zidovudine and interferon-beta in patients with AIDS-related Kaposi's sarcoma: AIDS Clinical Trials Group Protocol 057. Cytokines Cell Mol Ther. 1998 Mar;4(1):17-23.

  PMID: 9557213 BACKGROUND

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Interferon beta-1b; Zidovudine

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• S Miles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 1991
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (4)