The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Zidovudine; Interferon gamma-1b
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Zidovudine; Interferon-gamma
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Monocytes; Interferon-gamma, Recombinant; Injections, Subcutaneous; Immune System; Drug Evaluation; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Zidovudine; Blood Bactericidal Activity