SAFETY OF AUTOLOGOUS, EX-VIVO EXPANDED HUMAN-IMMUNODEFICIENCY-VIRUS (HIV)-SPECIFIC CYTOTOXIC T-LYMPHOCYTE INFUSION IN HIV-INFECTED PATIENTS

We infused six human immunodeficiency virus (HIV)-seropositive subject s with autologous CD8(+) cytotoxic T cells (CTLs) enriched for HIV-spe cific cytotoxicity targeted against a diversity of HIV epitopes in gp1 20, gag p17 and p24, and nef. There was no toxicity and no subject det eriorated clinically, In the first 2 weeks, CD4 counts increased for a ll subjects and plasma viremia decreased in five of six subjects. Twen ty-four weeks later, the mean values of all measures of viral burden a nd surrogate markers of HIV infection were either unchanged or improve d, but none of the changes was statistically significant. Two subjects continued to have decreased cell-associated viral burden and another subject had more than doubled CD4 cell count, HIV-specific CTL activit y increased in most subjects, The increase in CD4 T-cell counts in the first weeks after the infusion suggests that antiviral CTLs of divers e specificities do not play a significant role in CD4 T-cell decline. The lack of any acute toxicity or adverse effect on viral burden sugge sts that therapy with antiviral CTLs deserves further study. (C) 1997 by The American Society of Hematology.