Document 0371
 DOCN  M9550371
 TI    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.
 DT    9505
 AU    Reichman RC; Morse GD; Demeter LM; Resnick L; Bassiakos Y; Fischl M;
       Para M; Powderly W; Leedom J; Greisberger C; et al; Department of
       Medicine, University of Rochester School of; Medicine & Dentistry, NY
       14642.
 SO    J Infect Dis. 1995 Feb;171(2):297-304. Unique Identifier : AIDSLINE
       MED/95146774
 AB    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.
 DE    Adult  Antiviral Agents/*THERAPEUTIC USE  CD4 Lymphocyte Count  Drug
       Therapy, Combination  Human  HIV Infections/*DRUG THERAPY  HIV-1/*DRUG
       EFFECTS  Microbial Sensitivity Tests  Middle Age  Piperazines/ADVERSE
       EFFECTS/PHARMACOLOGY/PHARMACOKINETICS/  *THERAPEUTIC USE  Reverse
       Transcriptase/ANTAGONISTS & INHIB  Safety  Support, Non-U.S. Gov't
       Support, U.S. Gov't, P.H.S.  Time Factors  Zidovudine/*THERAPEUTIC USE
       CLINICAL TRIAL  CLINICAL TRIAL, PHASE I  JOURNAL ARTICLE

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