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Phase I study of atevirdine, a nonnucleoside reverse transcriptase inhibitor, in combination with zidovudine for human immunodeficiency virus type 1 infection. ACTG 199 Study Team.

Abstract
Twenty patients were enrolled in a phase I clinical trial of atevirdine, a nonnucleoside reverse transcriptase inhibitor (NNRTI), given in combination with zidovudine for treatment of human immunodeficiency virus type 1 (HIV-1) infection. Fifteen patients had received no previous antiretroviral therapy. HIV-1 isolates obtained at 6-week intervals were tested for sensitivity to atevirdine and zidovudine. Two patients developed a rash within 2 weeks of enrollment, and 1 of these developed concomitant fever and hepatitis. No hematopoietic, neurologic, or pancreatic toxicities were observed. Atevirdine had considerable initial interpatient pharmacokinetic variability. Forty-seven percent of patients treated with atevirdine plus zidovudine had increased CD4 lymphocyte counts, and HIV isolates from 62% of patients remained sensitive to atevirdine after 24 weeks of therapy. Atevirdine plus zidovudine was well-tolerated. Additional studies should be done to determine the role of atevirdine in the therapy for HIV infection.
AuthorsR C Reichman, G D Morse, L M Demeter, L Resnick, Y Bassiakos, M Fischl, M Para, W Powderly, J Leedom, C Greisberger
JournalThe Journal of infectious diseases (J Infect Dis) Vol. 171 Issue 2 Pg. 297-304 (Feb 1995) ISSN: 0022-1899 [Print] United States
PMID7531207 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Antiviral Agents
  • Piperazines
  • Reverse Transcriptase Inhibitors
  • Zidovudine
  • HIV Reverse Transcriptase
  • atevirdine
Topics
  • Adult
  • Antiviral Agents (therapeutic use)
  • CD4 Lymphocyte Count
  • Drug Therapy, Combination
  • HIV Infections (drug therapy)
  • HIV Reverse Transcriptase
  • HIV-1 (drug effects)
  • Humans
  • Microbial Sensitivity Tests
  • Middle Aged
  • Piperazines (adverse effects, pharmacokinetics, pharmacology, therapeutic use)
  • Reverse Transcriptase Inhibitors
  • Safety
  • Time Factors
  • Zidovudine (therapeutic use)

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