Document 2869
 DOCN  M94A2869
 TI    Efficacy of ZDV/DDC measured by surrogate markers.
 DT    9412
 AU    Banhegyi D; Ujhelyi E; Gerlei Z; Fust G; Saint Laszlo Hospital Dept. of
       Immunology, Budapest, Hungary.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):206 (abstract no. PB0255). Unique
       Identifier : AIDSLINE ICA10/94369706
 AB    OBJECTIVES: In a pilot study of the multicenter safety and tolerance
       study (M50002) the efficacy of ZDV/DDC (zidovudine/dideoxycytidine)
       combination were investigated by means of clinical signs and surrogate
       markers. METHODS: 15 patients (pts) who had been treated with ZDV (mean
       24.5 months; 16-40) and had disease progression in the last 6 month of
       treatment entered into this ZDV/DDC combination study. Pts were treated
       with 250 mg ZDV b.i.d. and 0.75 mg DDC t.i.d., according to the study
       design pts who developed mild adverse reactions were able to continue
       the treatment with a reduced dosage of DDC (0.375 mg t.i.d.). Six months
       before and during the 6 months of ZDV/DDC trial surrogate markers as
       CD4+ cells (absolute and percentage), serum p24 antigen, neopterin and
       beta-2-microglobulin as well as Karnofsky index, clinical progression
       were investigated. RESULTS: In group A: responder (AUCS of CD4+ > 110%,
       and either elevation of raw CD+ or CD+%) were 5 pts. In group B: stabile
       (AUCS of CD4+ 100 +/- 9%%, and no significant decrease in either of raw
       CD4+ or CD4+%) were 4 pts. In group C: non-responder (decrease in AUCS,
       absolute and percentage of CD4+) were 4 pts. There were two drop-outs.
       Neither progression to AIDS nor new AIDS defining diseases were
       observed. Dosage reduction of DDC was necessary in four pts out of whom
       three belonged to group A. Using other surrogate markers; in group A
       supported the improvement, where as in group B and C they were
       inconclusive. CONCLUSIONS: The introduction of ZDV/DDC therapy in pts
       with longer ZDV monotherapy and disease progression can benefit of this
       combination-therapy. Pts with CD4+ cell counts higher then 100/microL
       are more likely to take advantage of the combination.
 DE    beta 2-Microglobulin/*ANALYSIS  Antiviral Agents/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/  *THERAPEUTIC USE  Biopterin/*ANALOGS &
       DERIVATIVES/BLOOD  Comparative Study  Drug Therapy, Combination  Human
       HIV/ISOLATION & PURIF  HIV Core Protein p24/*BLOOD  HIV
       Infections/BLOOD/*DRUG THERAPY  *Karnofsky Performance Status  Leukocyte
       Count  Pilot Projects  Safety  Treatment Outcome  *T4 Lymphocytes
       Viremia/MICROBIOLOGY  Zalcitabine/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/*THERAPEUTIC  USE  Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/*THERAPEUTIC  USE  CLINICAL TRIAL  MEETING ABSTRACT  MULTICENTER
       STUDY

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