A Phase I Study To Determine the Safety of the Optimal Monocyte Activating Administration Schedule of Subcutaneous Human Recombinant Interferon-gamma in ZDV-Treated Patients With AIDS
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.
Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
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