       Document 0825
 DOCN  M9550825
 TI    Passive immunotherapy in AIDS: a double-blind randomized study based on
       transfusions of plasma rich in anti-human immunodeficiency virus 1
       antibodies vs. transfusions of seronegative plasma.
 DT    9505
 AU    Vittecoq D; Chevret S; Morand-Joubert L; Heshmati F; Audat F; Bary M;
       Dusautoir T; Bismuth A; Viard JP; Barre-Sinoussi F; et al; Service
       d'Infectiologie, Hopital Paul-Brousse, Villejuif,; France.
 SO    Proc Natl Acad Sci U S A. 1995 Feb 14;92(4):1195-9. Unique Identifier :
       AIDSLINE MED/95166796
 AB    A randomized double-blind controlled trial was conducted to determine
       the efficacy of passive immunotherapy in the treatment of symptomatic
       human immunodeficiency virus (HIV) infection. This trial included 86
       symptomatic patients randomized to receive plasma rich in anti-HIV-1
       antibody or standard seronegative plasma. Each patient in both groups
       received a 300-ml infusion every 14 days over a 1-year period, and every
       28 days thereafter, in addition to zidovudine and other conventional
       prophylactic treatments. Plasma donors were selected among symptomless
       seropositive individuals with a CD4 lymphocyte count > or = 400 x 10(6)
       cells per liter, a negative p24 antigen assay, and a high concentration
       of anti-p24 antibody. The plasmas were heat-inactivated before infusion.
       During the study period (day 28-day 365) scheduled by the protocol,
       clinical benefit from passive immunotherapy was observed in delaying the
       appearance of the first AIDS-defining event (P < 0.009) and reducing the
       cumulative incidence of such events, which was estimated 3-fold higher
       in the control group compared to the treatment group. Seven deaths
       occurred in the treatment group vs. 11 in the control group (P = 0.27).
       A total of 47 patients died or exhibited new AIDS-defining events, 18 in
       the treatment group and 29 in the control group (P = 0.009). No clinical
       benefit was observed after the 1-year period with infusions performed
       every 4 weeks. These results indicate a favorable effect of passive
       immunotherapy on the evolution of advanced AIDS.
 DE    Acquired Immunodeficiency Syndrome/*THERAPY  Adult  *Blood Transfusion
       Double-Blind Method  Female  Human  HIV Antibodies/*THERAPEUTIC USE  HIV
       Seronegativity  Immunoglobulins, Intravenous/*THERAPEUTIC USE
       Immunotherapy, Adoptive  Male  Middle Age  Support, Non-U.S. Gov't
       CLINICAL TRIAL  JOURNAL ARTICLE  RANDOMIZED CONTROLLED TRIAL

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

