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

J Infect Dis. 1995 Feb;171(2):297-304. doi: 10.1093/infdis/171.2.297.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • 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
  • Piperazines / pharmacokinetics
  • Piperazines / pharmacology
  • Piperazines / therapeutic use*
  • Reverse Transcriptase Inhibitors
  • Safety
  • Time Factors
  • Zidovudine / therapeutic use*

Substances

  • Antiviral Agents
  • Piperazines
  • Reverse Transcriptase Inhibitors
  • Zidovudine
  • HIV Reverse Transcriptase
  • atevirdine