Document 1040
 DOCN  M94A1040
 TI    Effect of a combination of growth hormone (rhGH) and insulin-like growth
       factor-I (rhIGF-I) on the appetite of HIV-1+ patients (PTS) with weight
       (WT) loss.
 DT    9412
 AU    Bukar JG; Jackson L; Muro J; Jenks BH; Bakst R; Brodsky M; Gesundheit N;
       Genentech, Inc., San Francisco, CA.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):222 (abstract no. PB0903). Unique
       Identifier : AIDSLINE ICA10/94371535
 AB    OBJECTIVE: To determine the effect of a combination of rhGH and rhIGF-I
       on the appetite of HIV-1+ pts with significant wt loss. METHODS: This
       was a double-blind study. HIV-1+ pts with either a body mass index (BMI)
       < or = 19.8 or a wt < or = 90% usual body weight (UBW) were randomized
       2:1 to either a combination of 0.34 mg rhGH bid +5 mg rhIGF-I bid (T
       pts) or placebo injections (P pts) for 6 weeks (wk). 52 T pts and 29 P
       pts participated in this food intake study which is part of a larger
       trial. Pts with known malabsorption or diarrhea (defined as > or = 5
       BM/day) or an inability to eat were excluded. Pts received a nutritional
       counseling session and recorded their food intake over 4 consecutive
       days at baseline (B) and wk 6. Food records were analyzed using
       Nutritionist 3 software and the following were determined: kcal/kg,
       grams protein/kg (pro/kg), % recommended daily allowances (RDA) kcal,
       and % RDA pro. Mean +/- SD B characteristics of the pts were: age = 36
       +/- 7 yrs, wt = 67 +/- 8 kg, % UBW = 85 +/- 5, BMI = 21 +/- 2, CD4+ =
       119/cmm +/- 189, %CD4+ = 8 +/- 10, alb = 4 +/- 0.3 g/dl. All pts were
       male. TABULAR DATA, SEE ABSTRACT VOLUME. The mean change from B to wk 6
       for: wt was 1 kg in T pts and 0 kg in P pts and for kcal/kg was 3 in
       both the T and P pts. No between group differences were found for change
       in CD4+ or alb from B to wk 6. DISCUSSION/CONCLUSIONS: A combination of
       0.34 mg rhGH bid + 5 mg rhIGF-I bid does not affect appetite in HIV-1+
       pts with significant wt loss. The ability of this dose to increase wt
       after 6 wks appears to be limited. However, changes in body composition
       may have occurred despite minimal changes in body wt. The lack of an
       effect on appetite does not appear to be due to a poor pharmacokinetic
       response since T pts blood IGF-I levels increased significantly at wk 6
       to above the upper limit of normal (100-400 ng/ml).
 DE    Adult  Appetite/*DRUG EFFECTS  Double-Blind Method  Drug Combinations
       Human  HIV Infections/*DRUG THERAPY/PHYSIOPATHOLOGY  Insulin-Like Growth
       Factor I/*ADMINISTRATION & DOSAGE  Male  Recombinant
       Proteins/ADMINISTRATION & DOSAGE  Somatotropin/*ADMINISTRATION & DOSAGE
       Weight Loss/*DRUG EFFECTS  CLINICAL TRIAL  MEETING ABSTRACT  RANDOMIZED
       CONTROLLED TRIAL

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