Document 0572
 DOCN  M9440572
 TI    Didanosine compared with continuation of zidovudine in HIV-infected
       patients with signs of clinical deterioration while receiving
       zidovudine. A randomized, double-blind clinical trial. The Bristol-Myers
       Squibb AI454-010 Study Group.
 DT    9404
 AU    Spruance SL; Pavia AT; Peterson D; Berry A; Pollard R; Patterson TF;
       Frank I; Remick SC; Thompson M; MacArthur RD; et al; Holy Cross
       Hospital, Salt Lake City, Utah.
 SO    Ann Intern Med. 1994 Mar 1;120(5):360-8. Unique Identifier : AIDSLINE
       MED/94136841
 AB    OBJECTIVE: To determine the benefits of switching to didanosine compared
       with continuing zidovudine among patients infected with human
       immunodeficiency virus (HIV) who have previously used zidovudine and
       have signs of clinical deterioration. DESIGN: Randomized, double-blind,
       two-armed, parallel, comparative clinical trial with a blinded,
       compassionate crossover provision at 12 weeks. SETTING: Outpatient
       clinics at 19 tertiary care medical centers. PATIENTS: 312 patients
       infected with HIV who had received zidovudine for 6 months or more, had
       CD4 cell counts of 300/mm3 or less, and had signs of clinical
       deterioration within 12 weeks before study entry. INTERVENTION: Peroral
       didanosine tablets (600 mg/d adjusted for weight, high dose) or
       zidovudine capsules (600 mg/d). MEASUREMENTS: Primary study end points
       were death, a new acquired immunodeficiency syndrome (AIDS)--defining
       event, or the combination of two new or recurrent HIV-related diagnoses
       with a 50% decrease in CD4 cells. RESULTS: Switching to didanosine was
       associated with fewer end points than continuing zidovudine (relative
       risk [RR] for zidovudine:didanosine = 1.5; 95% Cl, 1.1 to 2.0). This
       benefit was consistent across subgroups of patients with either
       AIDS-related complex or AIDS and was most apparent among those with a
       CD4 count at entry of 100/mm3 or more (RR = 2.2; Cl, 1.1 to 4.4).
       CONCLUSIONS: This study shows a positive treatment effect for switching
       from zidovudine to didanosine among patients with either AIDS-related
       complex or AIDS and validates the common practice of using clinical
       signs or a decrease in the CD4 count as an indication for changing
       therapy.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY/IMMUNOLOGY  Adult  Aged
       AIDS-Related Complex/*DRUG THERAPY/IMMUNOLOGY  Comparative Study
       Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE  Double-Blind Method  Female
       Human  Leukocyte Count  Male  Middle Age  Support, Non-U.S. Gov't  T4
       Lymphocytes  Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE  CLINICAL TRIAL
       JOURNAL ARTICLE  MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
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