COMBINATION TREATMENT WITH ZIDOVUDINE, THYMOSIN-ALPHA(1) AND INTERFERON-ALPHA IN HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

We have investigated the effects of combination therapy with thymosin alpha1 and natural human lymphoblastoid interferon-alpha in human immu nodeficiency virus infection and have shown that in vitro this combina tion treatment: (1) synergistically stimulated the cytotoxic activity against natural killer-sensitive target cells of lymphocytes collected from human immunodeficiency virus-infected donors and (2) did not int erfere with the antiviral activity of zidovudine. We thus studied the effects of combination therapy with thymosin alpha1, interferon-alpha and zidovudine in patients with CD4+ lymphocytes ranging from 200 to 5 00/mm3 in a randomized non-blinded study and found that the treatment was well tolerated after 12 months of therapy and was associated with a substantial increase in the number and function of CD4+ T cells. A s imilar effect was not observed in human immunodeficiency virus patient s treated with zidovudine alone or associated with single agents. Thes e data suggest the need for a controlled, double-blind clinical trial, recently initiated with the approval and the support of the Italian M inistry of Health.