A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients With AIDS Related Complex
Condition: HIV Infections
MeSH terms: AIDS-Related Complex; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the tolerance and toxicity of the combination of tumor necrosis factor (TNF) and
      interferon gamma (IFN-G) or as single agent TNF or IFN-G in HIV infected patients. To
      selectively monitor the immune system of AIDS related complex (ARC) patients who receive
      either combination therapy or TNF or IFN-G alone. To obtain information on the effectiveness
      of combination therapy or TNF or IFN-G alone against HIV in ARC patients.

      Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which
      causes AIDS and ARC in some laboratory studies, but may increase virus replication in other
      laboratory studies. Previous studies in humans showed no increase in virus cultures and some
      decrease in measurements of virus. Extensive preclinical data show that TNF and IFN-G are
      more effective together than separately in laboratory and animal studies. As single agents,
      both TNF and IFN-G have modest effect against HIV. Studies have demonstrated that TNF and
      IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells, but
      also can selectively induce the destruction of acutely infected target cells.
    

Detailed description: 
      Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which
      causes AIDS and ARC in some laboratory studies, but may increase virus replication in other
      laboratory studies. Previous studies in humans showed no increase in virus cultures and some
      decrease in measurements of virus. Extensive preclinical data show that TNF and IFN-G are
      more effective together than separately in laboratory and animal studies. As single agents,
      both TNF and IFN-G have modest effect against HIV. Studies have demonstrated that TNF and
      IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells, but
      also can selectively induce the destruction of acutely infected target cells.

      Patients with ARC who are positive for HIV antibody are randomized to receive one of three
      treatment arms: (1) TNF alone by intramuscular injection (IM); (2) IFN-G alone by IM; (3) TNF
      plus IFN-G. Patients receive IM injections 3 times weekly for 4 months (16 weeks). Repeated
      physical examinations and laboratory tests are used to monitor patients' safety. Serial HIV
      cultures and core antigen assays are employed to obtain evidence of antiviral activity and
      serial T cell and skin tests are used to measure immunologic effect.
    

Intervention name(s): Tumor Necrosis Factor; Interferon gamma-1b
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Interferon-gamma
Masking: Double
Primary purpose: Treatment
Keywords: Tumor Necrosis Factor; Interferon-gamma, Recombinant; HIV Antigens; Immunologic Surveillance; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex