Document 2844
 DOCN  M94A2844
 TI    Standard vs low dose ZDV+DDI therapy in PTS with failure of ZDV
       monotherapy.
 DT    9412
 AU    Narciso P; Tozzi V; Sette P; Alba L; Grisetti S; Colaiacomo M;
       Campitelli G; Missori R; Visco G; L. Spallanzani Hosp., USL RM/10 Rome,
       Italy.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):211 (abstract no. PB0272). Unique
       Identifier : AIDSLINE ICA10/94369731
 AB    OBJECTIVE. To determine efficacy and tolerance of standard dose (SD) vs
       low dose (LD) ZDV+DDI combination therapy in patients who failed prior
       ZDV monotherapy. METHODS. Design: open, prospective, randomized.
       Eligibility criteria: ZDV monotherapy for more than 6 months, occurrence
       of a decrease in CD4+ cell count of at least 25% in two consecutive
       determinations and/or disease progression. Treatment regimens: ZDV 250
       mg/bid plus DDI 200 mg/bid vs ZDV 100 mg/tid plus DDI 150 mg/bid.
       Follow-up: clinical and laboratory controls, including lymphocyte
       subsets and p24 Ag levels every month. Clinical endpoints: mortality,
       frequency and severity of opportunistic infections, tumors and other CDC
       IV events. infections, tumors and other CDC IV events. RESULTS. Mean
       follow up was 5.9 and 5.6 months (SD and LD respectively). TABULAR DATA,
       SEE ABSTRACT VOLUME. No differences in clinical events and deaths
       between the two groups was observed. HIV p24 Ag levels showed no
       significative modifications in both groups. Withdrawal occurred in 8 pts
       (SD = 7, LD = 1). Main side effects were gastrointestinal complaints (n
       = 4), pancreatic dysfunction (n = 3) and neuropathy (n = 1).
       CONCLUSIONS. ZDV+DDI combination therapy can reverse of the progressive
       fall in CD4+ cell count in pts with ZDV failure. Positive effects were
       no longer seen after the fourth month. Low dose ZDV+DDI combination
       therapy seems as effective as standard dose but better tolerated.
 DE    Didanosine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE
       Drug Therapy, Combination  Gastrointestinal Diseases/CHEMICALLY INDUCED
       Human  HIV Infections/*DRUG THERAPY/MORTALITY  Pancreatitis/CHEMICALLY
       INDUCED  Peripheral Nervous System Diseases/CHEMICALLY INDUCED
       Prospective Studies  Treatment Failure  Zidovudine/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE  CLINICAL TRIAL  MEETING
       ABSTRACT  RANDOMIZED CONTROLLED TRIAL

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