The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine

NCT00001112 | Completed Phase 1

• 2 other identifiers: ACTG 07211046
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Monocytes; Interferon-gamma, Recombinant; Injections, Subcutaneous; Immune System; Drug Evaluation; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Zidovudine; Blood Bactericidal Activity

Interventions

Zidovudine DRUG

Interferon gamma-1b DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cornell University A2201

New York, New York, 10021, United States

Location

Related Publications (1)

• Murray HW, Scavuzzo D, Jacobs JL, Kaplan MH, Libby DM, Schindler J, Roberts RB. In vitro and in vivo activation of human mononuclear phagocytes by interferon-gamma. Studies with normal and AIDS monocytes. J Immunol. 1987 Apr 15;138(8):2457-62.

  PMID: 3104467 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Zidovudine; interferon gamma-1b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• HW Murray

  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: April 1, 1993
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)