Document 0814
 DOCN  M9590814
 TI    A phase I/II study of 2'-deoxy-3'-thiacytidine (lamivudine) in patients
       with advanced human immunodeficiency virus infection.
 DT    9509
 AU    Pluda JM; Cooley TP; Montaner JS; Shay LE; Reinhalter NE; Warthan SN;
       Ruedy J; Hirst HM; Vicary CA; Quinn JB; et al; Medicine Branch, National
       Cancer Institute, Bethesda, MD 20852,; USA.
 SO    J Infect Dis. 1995 Jun;171(6):1438-47. Unique Identifier : AIDSLINE
       MED/95287033
 AB    In a phase I/II trial assessing the toxicity, pharmacokinetics, and
       activity of the (-)enantiomer of 2'-deoxy-3'-thiacytidine (3TC,
       lamivudine), 97 patients with AIDS or advanced human immunodeficiency
       virus (HIV) disease were administered 3TC at 0.5-20.0 mg/kg/day. The
       cohort's median entry CD4 cell count was 128/mm3 (range, 7-357). A toxic
       dose was not reached, although some patients reported mild headache,
       insomnia, and abdominal symptoms, and there was a general downward trend
       in neutrophil counts at the highest doses. Although subjective and
       difficult to interpret, increases in energy and appetite were noted,
       particularly in patients receiving > or = 8.0 mg/kg/day. Immunologic and
       virologic parameters showed evidence of at least transient anti-HIV
       activity at those higher doses. Although further studies of 3TC as
       monotherapy are needed, its favorable toxicity profile, evidence of at
       least transient clinical activity, and results of in vitro resistance
       experiments support further clinical testing in combination therapy.
 DE    beta 2-Microglobulin/METABOLISM  Acquired Immunodeficiency
       Syndrome/*DRUG THERAPY  Adult  Female  Human  HIV Core Protein p24/BLOOD
       HIV Infections/*DRUG THERAPY  Male  Middle Age  Support, Non-U.S. Gov't
       Time Factors  Zalcitabine/*ANALOGS & DERIVATIVES/ADVERSE EFFECTS/
       PHARMACOKINETICS/THERAPEUTIC USE  CLINICAL TRIAL  CLINICAL TRIAL, PHASE
       I  CLINICAL TRIAL, PHASE II  JOURNAL ARTICLE  MULTICENTER STUDY

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