A Randomized Multicenter Phase II Trial of Recombinant Tumor Necrosis Factor and Recombinant Human Interferon-gamma in Patients With AIDS Related Complex
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
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.
Masking: Double-Blind, Primary Purpose: Treatment
United States: Federal Government
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