       Document 0171
 DOCN  M9440171
 TI    A comparative trial of didanosine or zalcitabine after treatment with
       zidovudine in patients with human immunodeficiency virus infection. The
       Terry Beirn Community Programs for Clinical Research on AIDS [see
       comments]
 DT    9404
 AU    Abrams DI; Goldman AI; Launer C; Korvick JA; Neaton JD; Crane LR;
       Grodesky M; Wakefield S; Muth K; Kornegay S; et al; San Francisco
       Community Consortium on AIDS, University of; California.
 SO    N Engl J Med. 1994 Mar 10;330(10):657-62. Unique Identifier : AIDSLINE
       MED/94150516
 CM    Comment in: N Engl J Med 1994 Mar 10;330(10):706-7
 AB    BACKGROUND. Both didanosine and zalcitabine are commonly used to treat
       patients with human immunodeficiency virus (HIV) infection who cannot
       tolerate zidovudine treatment or who have had disease progression
       despite it. The relative efficacy and safety of these second-line
       therapies are not well defined. METHODS. In this multicenter, open-label
       trial we randomly assigned 467 patients who previously received
       zidovudine and had 300 or fewer CD4 cells per cubic millimeter or a
       diagnosis of the acquired immunodeficiency syndrome (AIDS) to treatment
       with either didanosine (500 mg per day) or zalcitabine (2.25 mg per
       day). RESULTS. After a median follow-up of 16 months, disease
       progression or death occurred in 157 of 230 patients assigned to
       didanosine and 152 of 237 patients assigned to zalcitabine, for a
       relative risk of 0.93 for the zalcitabine group as compared with the
       didanosine group (P = 0.56), which decreased to 0.84 (P = 0.15) after
       adjustment for the CD4 count, Karnofsky score, and presence of AIDS at
       base line. There were 100 deaths in the didanosine group and 88 in the
       zalcitabine group, for a relative risk of 0.78 (P = 0.09) and an
       adjusted relative risk of 0.63 (P = 0.003). A majority of patients in
       each group (66 percent) had at least one adverse event during treatment
       (153 patients taking didanosine and 157 taking zalcitabine). Peripheral
       neuropathy and stomatitis occurred more often with zalcitabine and
       diarrhea and abdominal pain more frequently with didanosine.
       CONCLUSIONS. For patients with HIV infection who have not responded to
       treatment with zidovudine, zalcitabine is at least as efficacious as
       didanosine in delaying disease progression and death.
 DE    Acquired Immunodeficiency Syndrome/DRUG THERAPY/IMMUNOLOGY/  MORTALITY
       Adult  Comparative Study  Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE
       Female  Follow-Up Studies  Human  HIV Infections/*DRUG
       THERAPY/IMMUNOLOGY/MORTALITY  Leukocyte Count  Male  Risk  T4
       Lymphocytes  Zalcitabine/ADVERSE EFFECTS/*THERAPEUTIC USE
       Zidovudine/*THERAPEUTIC USE  CLINICAL TRIAL  JOURNAL ARTICLE
       MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

