Antiviral activity and change in CD4⁺T-cell count following CD4ζ-modified T-cell infusion.

Baseline values represent an average of those at week −1 and week 0. T-cell infusion occurred at week 0, and postinfusion analyses were performed on days 1, 2, and 3 and weeks 2, 4, and 8. Scr1 and 2 represent the 2 screening values performed approximately 8 weeks before cell infusion. (A) Mean change from baseline in plasma HIV RNA (Roche Amplicor kit; sensitivity 40 copies/mL). There were no statistically significant differences between the cells only (▴) and cells + IL-2 (▪) cohorts at any time point after infusion (P = .87, week 2; P = .70, week 4; P = .86, week 8). (B) Mean change from baseline in blood HIV proviral DNA (DNA PCR for HIVgag, Specialty Labs; sensitivity 35 copies/10⁶cells). There were no statistically significant differences between the cells only (▴) and cells + IL-2 (▪) cohorts at any time point after infusion (P = .84, week 2; P = .94, week 4; P = .89, week 8). (C) Mean change from baseline in CD4⁺ T-cell count. There was a trend toward a greater increase in CD4⁺ T-cell counts after infusion in the cells + IL-2 arm (▪) compared with the cells-only arm (▴) (P = .04, week 2; P = .14, week 4;P = .10, week 8).