Document 1034
 DOCN  M94A1034
 TI    A pilot Italian study with megestrol acetate (MA) in AIDS related
       cachexia.
 DT    9412
 AU    Vigano M; Danise A; Novati R; Finazzi R; Gaiera G; Lazzarin A; Dep.
       Infect. Dis., Scientific Institute H S.Raffaele, Milan,; Italy.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):224 (abstract no. PB0908). Unique
       Identifier : AIDSLINE ICA10/94371541
 AB    OBJECTIVES: Cachexia is a common problem in patients infected with HIV
       and predicts a poor prognosis. The deleterious effects of malnutrition
       on immunity to infection are well recognized. We report about a
       randomized open pilot italian study with three dosages of MA in patients
       with AIDS related cachexia. to evaluate: 1) the efficacy of MA in
       increasing body weight or in preventing weight loss in patients with
       AIDS, 2) the safety of this treatment in AIDS patients; 3) the role of
       some biological and immunological parameters in pathogenesis of
       cachexia; 4) the best dosage of MA in such patients. METHODS: Sixteen
       patients with AIDS and cachexia were randomized to receive oral MA at
       doses of 320, 480 and 800 mg/d for 12 weeks. Patients had a mean weight
       loss of 16.9%. Anthropo-metric measurements and questionnaires on the
       patients' perception of their well-being were obtained. RESULTS: All
       valuable patients gained weight. The average weight gain after 12 weeks
       in the three groups is showed below (two patients were early lost to
       follow up). TABULAR DATA, SEE ABSTRACT VOLUME. TNF and IL-2 serum levels
       were unaffected by the treatment. Neopterin levels slightly decreased
       after therapy. Three patients developed potentially drug-related side
       effects (deep-vein thrombosis, diabetes insipidus and mild peripheral
       edema). CONCLUSIONS: This pilot study shows encouraging suggestions on
       appetite improvement and weight gain in AIDS patients receiving MA. The
       true benefit of MA for AIDS-related cachexia and its effects on the
       quality of life should be assessed by a placebo-controlled trial and an
       higher number of patients is needed to determine the best dosage of MA.
 DE    Acquired Immunodeficiency Syndrome/*COMPLICATIONS  Administration, Oral
       Cachexia/*DRUG THERAPY/ETIOLOGY  Human  Interleukin-2/ANALYSIS
       Megestrol/*ANALOGS & DERIVATIVES/ADMINISTRATION & DOSAGE/  THERAPEUTIC
       USE  Pilot Projects  Tumor Necrosis Factor/ANALYSIS  Weight Loss/DRUG
       EFFECTS  CLINICAL TRIAL  MEETING ABSTRACT  RANDOMIZED CONTROLLED TRIAL

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