Document 2878
 DOCN  M94A2878
 TI    Todoxin in AIDS. Phase 3 controlled multinational cooperative open
       study. Todoxin Study Group.
 DT    9412
 AU    Radojicic C; Jovanovic T; Petrovic S
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no. PB0243). Unique
       Identifier : AIDSLINE ICA10/94369697
 AB    OBJECTIVE: To determine the efficacy of TODOXIN (see also Track A14 and
       D17/D18) to delay the onset of AIDS. METHODS: 20 HIV+ patients (pts)
       were stratified into 2 groups at study entrance. (G1): CD4 < 300/6 IVDU,
       2 HEM, 2 HS/sero+ 1982-89, 9 CDC 4a, 2 CDC 4b and (G2): CD4 > or = 300/4
       IVDU, 2 HEM, 2 HS/sero+ 1985-91, 1 CDC 2, 6 CDC 3, 2 CDC 4a. Both groups
       were treated with TODOXIN, 0,3 ml/kg BW orally in 2-4 hr intervals, 28
       days, 1 or 2 times per year up to the present. Each group included a
       control patient (CP1, CP2) who received one single treatment 28 days at
       study entrance. Clinical and immunological parameters were followed in
       all patients for up to 72 months per patient through laboratories in New
       York, London, Stockholm, Paris, Munich, Belgrade and Florence. RESULTS:
       Mean change under treatment compared to baseline (BL) at study entrance:
       Mo/Ma#: +538 (+1.862, -467)% in all (n = 5) patients with BL Mo/Ma <
       200/mm3 (107 + 63, -77) and -14 (+5, -4)% in all patients with BL Mo/Ma
       > 200/mm3 (400 + 400, -120) irrespective of group. CD 16,CD56#:
       +121(+97, -31)% in G2 and +91 (+102, -110)% in G1. NK/LGL cytotoxicity:
       (K 562, 50:1) +98 (+48, -54)% in all patients (n = 5) with low BL
       (12,5-19,4%) CD8#: increased CD8+,HLA-DR+ subset representing up to 75%
       of total CD8 irrespective of group. CD25(IL-2): +317(+283, -284)% in G2.
       CD19#: +69 (+91, -56)% in G1, +69(+102, -57)% in G2. Virology (p24/25):
       all (n = 5) incl. CP 1 BL a/g+ patients became and continue to be a/g-
       up to 60 months (incl. CP 1). Clinical parameters: 9 out of 11 pts in G1
       and 8 out of 9 pts in G2 are in complete remission as per HIV- risk
       group controls (3 pts with decreased DCH), 2 pts have palpable lymph
       nodes involvement without signs attributed to PGL. In G1 9 CDC 4a pts
       regressed to CDC 1 and 2 CDC 4c pts regressed to CDC 2 and in G2 6 CDC 3
       pts regressed to CDC 1, 1 CDC 2 regressed to CDC 1 and 2 CDC4a pts
       regressed to CDC 2. No patient progressed to AIDS. CONCLUSION: Todoxin
       administered 2 times 28 days per year obtains regression of disease and
       prevents the onset of AIDS in an observation period of 270 pts months in
       G1 and 147 pts months in G2. In addition to the latest data on this
       ongoing study results shall be presented of enlarged double blind
       placebo controlled study. TABULAR DATA, SEE ABSTRACT VOLUME.
 DE    Antiviral Agents/*THERAPEUTIC USE  Comparative Study  Double-Blind
       Method  Human  HIV Infections/BLOOD/*DRUG THERAPY  Leukocyte Count
       Treatment Outcome  T4 Lymphocytes  CLINICAL TRIAL  CLINICAL TRIAL, PHASE
       III  MEETING ABSTRACT  MULTICENTER STUDY

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