Document 1165
 DOCN  M94A1165
 TI    Experience with stavudine (d4T) therapy of patients with advanced AIDS
       and < 50 CD4 cells.
 DT    9412
 AU    Pottage J Jr; Benson C; Sha B; Rush Medical College, Chicago, IL.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):194 (abstract no. PB0790). Unique
       Identifier : AIDSLINE ICA10/94371410
 AB    OBJECTIVE: To characterize the clinical response to therapy with d4T in
       patients with advanced AIDS. METHODS: From 1/93-2/94, patients with AIDS
       and < 50 CD4 cells/mm3 were enrolled, evaluated, and treated according
       to the d4T treatment IND protocol. Data were collected monthly and
       included age, prior antiretroviral therapy, weight, Karnofsky score, CD4
       count, status of prior and new HIV-related events, and adverse
       reactions. RESULTS: Twenty-one patients (19 men, 2 women) were enrolled.
       The median age was 40 years, all patients had been previously treated
       with antiretrovirals for a median of 40 months (range 8-80 months) and
       all had progression of their HIV disease prior to entry. The median
       baseline CD4 count was 6 cells/mm3 (range 0-42). The median baseline
       Karnofsky score was 70 (range 60-100). No improvement in CD4 count,
       Karnofsky score, or weight was noted following a median duration of d4T
       treatment of 8 months (range 2-13 months). Seventeen of 21 patients had
       development of new or progression of prior HIV-related conditions. The
       median time from initiation of d4T to a new HIV-related event was four
       months. Of the 34 events occurring in 17 patients, the most frequent
       were bacteremia (7), PCP (5), Candida esophagitis (4), CMV retinitis
       (3), and wasting (3). Adverse reactions occurred in 9/21 patients
       (peripheral neuropathy-6, neutropenia-2, hepatitis-1). Twelve patients
       have discontinued d4T (worsening HIV disease-8, toxicity-4). Eight
       patients have died due to progression of AIDS. Median survival is > 11
       months (Kaplan-Meier). CONCLUSION: Although the development of new or
       progression of prior HIV-related conditions continues to occur
       frequently, d4T therapy is relatively well tolerated and may improve
       survival in AIDS patients with CD4 counts < 50 cells/mm3.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY  Adult  Female  Human
       Leukocyte Count  Male  Stavudine/IMMUNOLOGY/*THERAPEUTIC USE  T4
       Lymphocytes  CLINICAL TRIAL  MEETING ABSTRACT

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