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The Safety and Effectiveness of Injections of Human Recombinant Interferon-Gamma in Patients With AIDS Who Have Taken Zidovudine
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001112
  Purpose

To find out which of four doses of (recombinant) human interferon gamma (IFN-G) is most effective in stimulating the white blood cells (monocytes) to fight infection and to see if treatment with IFN-G can strengthen the ability of AIDS patients to control infections. This study will also determine how long after a single injection of IFN-G white blood cells remain stimulated.

AIDS is a disease that progressively destroys that aspect of the body's defense called the immune system. It is particularly harmful to a class of cells called helper T-lymphocytes. The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often poorly tolerated by the patients and are associated with dose-limiting toxicities. The principal focus of AIDS therapy research at present is to control the underlying retroviral infection and to restore immune function with recombinant lymphokines, adoptive immunotherapy, and/or lymphocyte transplants. These treatments include zidovudine (AZT), which has been shown to control the HIV infection, and IFN-G, a lymphokine which activates tumor-destroying and germ-killing functions. Studies are needed to find the dose by which IFN-G works best.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Interferon gamma-1b
Phase I

MedlinePlus related topics: AIDS
Drug Information available for: Zidovudine Interferons Interferon gamma-1b
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase I Study To Determine the Safety of the Optimal Monocyte Activating Administration Schedule of Subcutaneous Human Recombinant Interferon-Gamma in ZDV-Treated Patients With AIDS

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 5
Detailed Description:

AIDS is a disease that progressively destroys that aspect of the body's defense called the immune system. It is particularly harmful to a class of cells called helper T-lymphocytes. The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often poorly tolerated by the patients and are associated with dose-limiting toxicities. The principal focus of AIDS therapy research at present is to control the underlying retroviral infection and to restore immune function with recombinant lymphokines, adoptive immunotherapy, and/or lymphocyte transplants. These treatments include zidovudine (AZT), which has been shown to control the HIV infection, and IFN-G, a lymphokine which activates tumor-destroying and germ-killing functions. Studies are needed to find the dose by which IFN-G works best.

Patients, who may participate in all three parts of the study, are maintained on a stable dose of AZT. In part A (optimal dose), five AIDS patients who have had an AIDS related opportunistic infection receive 4 once-weekly increasing doses of IFN-G. Monocyte antimicrobial activity is examined in test tube studies before and after each injection of IFN-G. In part B, five patients receive the optimal dose of IFN-G established in part A. Patients enrolled from part A have completed at least 2 weeks of part A before enrolling in part B. Antimicrobial activity is examined 1, 2, and 3 days after a single injection of the optimal dose of IFN-G (determined in part A). In part C (safety and tolerance of combined treatment of IFN-G and AZT), patients are treated with IFN-G for 4 weeks using the optimal dose and administration schedule derived from parts A and B.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylactic antibiotics.
  • Tylenol (650 mg orally every 6 hours as needed for temperature > 38.5 degrees C).
  • Meperidine (25 - 50 mg intravenously, once, for severe rigors if systolic blood pressure is > 90 mmHg).

Patients must meet criteria for AIDS classification (CDC) category IV C-1.

  • Patients must have had one or more prior opportunistic infections identified in surveillance definition of AIDS. Patients whose AIDS-defining illness is Kaposi's sarcoma are also eligible if they have previously had one of the secondary infectious diseases identified in category C-1.

Prior Medication:

Required:

  • Patients must have been receiving zidovudine (AZT) on a stable dosage regimen for at least 8 weeks immediately preceding entry into study.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Clinically significant cardiac (= or > class II, New York Heart Association) or peripheral vascular disease that requires treatment.
  • Presence of an active opportunistic infection that requires treatment.
  • Hemorrhagic diathesis or active bleeding disorder.
  • Clinically apparent vascular disease.

Concurrent Medication:

Excluded:

  • Medications required for treatment of active cardiac disease.
  • Ongoing therapy with anticoagulants or thrombolytic agents.

Patients with the following are excluded:

  • Clinically significant cardiac (= or > class II, New York Heart Association) or peripheral vascular disease that requires treatment.
  • Presence of an active opportunistic infection that requires treatment.
  • Hemorrhagic diathesis or active bleeding disorder.
  • Clinically apparent vascular disease.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Antiviral chemotherapy other than zidovudine.
  • Excluded within 12 weeks of study entry:
  • Immunosuppressive or cytotoxic therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001112

Locations
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
Sponsors and Collaborators
Investigators
Study Chair: HW Murray
  More Information

Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG 072
Study First Received: November 2, 1999
Last Updated: July 14, 2008
ClinicalTrials.gov Identifier: NCT00001112  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Monocytes
Interferon-gamma, Recombinant
Injections, Subcutaneous
Immune System
Drug Evaluation
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Zidovudine
Blood Bactericidal Activity

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Interferon Type II
HIV Infections
Interferons
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes
Interferon-gamma, Recombinant

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009