Efficacy and safety of delavirdine mesylate with zidovudine and didanosine compared with two-drug combinations of these agents in persons with HIV disease with CD4 counts of 100 to 500 cells/mm3 (ACTG 261)

Gerald H. Friedland, Richard Pollard, Brigitte Griffith, Michael Hughes, Gene Morse, Roland Bassett, William Freimuth, Lisa Demeter, Elizabeth Connick, Thomas Nevin, Martin Hirsch, Margaret A Fischl

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33 Citations (Scopus)

Abstract

To evaluate the antiretroviral activity of delavirdine mesylate, a nonnucleoside reverse transcriptase inhibitor of HIV-1, we performed a phase II, randomized, double-blind, multicenter trial comparing the three-drug combination of delavirdine with zidovudine and didanosine to two-drug combinations of these drugs. Patients with CD4 cell counts between 100 and 500 cells/mm3 without prior or <6 months of monotherapy with zidovudine or didanosine were randomized to one of four arms and observed on a follow-up basis for 48 weeks. In total, 544 patients were evaluated. In those assigned to the three-drug regimen, mean short-term (weeks 4-12) and long-term (weeks 40-48) change in CD4 cells from baseline were 49.3 ± 8.1 and 65.4 ± 13.4 cells/mm3, respectively; mean short-term and long-term HIV-1 RNA changes from baseline were -1.13 log10 ± 0.12 and -0.73 ± 0.12 copies/ml, respectively. These responses in CD4 cell counts and HIV-1 RNA levels were better in comparisons with each of the two-drug arms at all study points; however, differences were not consistently significant. Gastrointestinal side effects were experienced by 33% of patients (178 of 544), and 30% (121 of 407) receiving delavirdine experienced rash, only one case of which was severe. In this study, therapy with delavirdine + zidovudine + didanosine was safe and showed modest, but not always significant, antiviral activity and CD4 cell count benefit compared with two-drug regimens with these agents.

Original languageEnglish
Pages (from-to)281-292
Number of pages12
JournalJournal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Volume21
Issue number4
StatePublished - Aug 1 1999

Fingerprint

Delavirdine
Didanosine
Zidovudine
Drug Combinations
CD4 Lymphocyte Count
HIV
Safety
HIV-1
Pharmaceutical Preparations
RNA
Reverse Transcriptase Inhibitors
Exanthema
Multicenter Studies
Antiviral Agents

Keywords

  • Antiretroviral therapy
  • Delavirdine mesylate
  • Nonnucleoside reverse transcriptase inhibitors

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Virology

Cite this

Efficacy and safety of delavirdine mesylate with zidovudine and didanosine compared with two-drug combinations of these agents in persons with HIV disease with CD4 counts of 100 to 500 cells/mm3 (ACTG 261). / Friedland, Gerald H.; Pollard, Richard; Griffith, Brigitte; Hughes, Michael; Morse, Gene; Bassett, Roland; Freimuth, William; Demeter, Lisa; Connick, Elizabeth; Nevin, Thomas; Hirsch, Martin; Fischl, Margaret A.

In: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, Vol. 21, No. 4, 01.08.1999, p. 281-292.

Research output: Contribution to journalArticle

Friedland, Gerald H. ; Pollard, Richard ; Griffith, Brigitte ; Hughes, Michael ; Morse, Gene ; Bassett, Roland ; Freimuth, William ; Demeter, Lisa ; Connick, Elizabeth ; Nevin, Thomas ; Hirsch, Martin ; Fischl, Margaret A. / Efficacy and safety of delavirdine mesylate with zidovudine and didanosine compared with two-drug combinations of these agents in persons with HIV disease with CD4 counts of 100 to 500 cells/mm3 (ACTG 261). In: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology. 1999 ; Vol. 21, No. 4. pp. 281-292.
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AU - Griffith, Brigitte

AU - Hughes, Michael

AU - Morse, Gene

AU - Bassett, Roland

AU - Freimuth, William

AU - Demeter, Lisa

AU - Connick, Elizabeth

AU - Nevin, Thomas

AU - Hirsch, Martin

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