Delavirdine mesylate (DLV) in two and three drug combinations with zidovudine(ZDV)and didanosine (ddI), (ACTG261)

G. H. Fredland, M. A. Fischl, R. B. Pollard, B. P. Griffith, M. Hughes, R. Bassett, W. Freimuth, T. Nevin

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Abstract

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 languageEnglish (US)
Number of pages1
JournalClinical Infectious Diseases
Volume25
Issue number2
StatePublished - Dec 1 1997
Externally publishedYes

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    Fredland, G. H., Fischl, M. A., Pollard, R. B., Griffith, B. P., Hughes, M., Bassett, R., Freimuth, W., & Nevin, T. (1997). Delavirdine mesylate (DLV) in two and three drug combinations with zidovudine(ZDV)and didanosine (ddI), (ACTG261). Clinical Infectious Diseases, 25(2).