A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients With AIDS Related Complex
Status:
Completed
Trial end date:
1990-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)