ACTG 261 compared 3-drug combination of DLV+ZDV+ddI to 2-drug combinations of DLV+ZDV, DLV+ddI, and ZDV+ddI in patients with CD4 cell counts 100 io 500 cells/mm3, and ≤6 mo of prior therapy with either ZDV or ddI. Of 544 patients analysed, median baseline CD4, 295 cells/mm3, 36% reported prior ZDV use, 1% ddI. Of 247 in virology substudy ACTG 825, median baseline HIV-1 RNA 29,324 copies/mL. Results showed significant short term (mean wks 4, 8, 12) CD4 difference between the 4 treatment arms (four-way p=0.009); greater mean increases for DLV+ ZDV+ddI (49 cells/mm3) than DLV+ZDV (17 cell/mm3, p=0.003) but not DLV+ ddI (33 cells/mm3) or ZDV+ddI (48 cells/mm3); significant long term (mean 40, 48 wks) difference between the 4 treatment arms (four-way p<0.001); greater mean increases DLV+ZDV+ddI (65 cells/mm3) than DLV+ZDV (decrease 9 cells/ mm3, p<0.001) and DLV+ddI (26 cells/mm3, p=0.011) but not ZDV+ddI (44 cells/ mm3). Preliminary analyses of plasma HIV-1 RNA showed significant short term difference between the 4 treatment arms (four-way p<0.001) greater mean decreases for DLV +ZDV+ddI (1.12 log10 copies/mL) than DLV+ZDV (0.49 log10 copies/mL, p<0.001) and DLV+ddI (0.76 logic copies/mL, p=0.007) bul not ZDV+ddI (0.88 logio copies/mL, p=0.15). Mean long term decreases were similar (0.97 log10 copies/mL for DLV +ZD V +ddI, 0.54 for DLV+ZDV, 0.82 for DLV+ddI and 0.65 for ZDV+ddI). There were no significant differences in toxicities among the 4arms DLV showed moderate activity vs HIV-1 in combination with ZDV and ddI with better mean responses in CD4 count and HIV-1 RNA level than each of the two-drug combinations. Differences were not significant for comparisons between DLV+ZDV+ddI and ZDV+ddI.
|Original language||English (US)|
|Number of pages||1|
|Journal||Clinical Infectious Diseases|
|State||Published - 1997|
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