Abstracts Vol. 1 [International Conference on AIDS (11th: 1996: Vancouver, Canada)]

Monday, July 8, 1996

Mo.B.421 - Mo.B.425

Conclusions: Our data are suggestive for the presence of biolo;,.! 'csoe GH in AIDS
patients.The low GH activity associated with the impaired IGFI c:" +:lJ r te may be
responsible for both metabolic and irrmmunological alterations (e.g. i resed catabolic
pattern, reduced T-cell generation and activity), while rhGH treatrert i. restores a normal
24-h IGFI profile. It is presumable that the reduced activity of GCI I. IE1P1 I t1,3 axis in
AIDS patients might represent a defensive rmechanisrm against HIs ' i.n into the
immune system.
S.B.Solerte, Dept. Internal Medicine, Ospedale S.Margherita, Piazz, b,r o: io, 2,)7100 Pavia
(Italy) Tel.:[phone] Fax: [phone]
Mo.B.42 I
DIFFERENT BODY COMPOSITION CHANGES IN MEN AND WOMEN WITH AIDS
Kotler Donald P*, Engelson ES*,Thea DM*,Wang J*, Pierson RN n t ui, *, Keusch
GT***. *St. Luke's Roosevelt Hospital Center, Columbia Univ., NY IN U.SA. tufts
University, Boston, MA, USA. *Centers for Disease Control and Prevention, tlantta, GA, USA.
Objective: To compare the effects of gender, race, environmsent, aI1;i, (/IDS) upon
body composition and upon the relative depletion of body cell ns,, (BC'i, t tree mass
(FFM) and body fat.
Methods: We analyzed the results of body composition studies peni rmed in two cohorts
of subjects, totalling 1415 people, including adult Caucasian and AfIric.r Anr ecan rsen and
women, and African men and women, of which 279 were clinically il AID5) patiernts and the
other 1I 136 were controls. Body compositior was analyzed by bioirnpediance analysis (RJL
Systems). Stepwise multiple regression analysis was used to determin<' the relative effects of
race, gender, environment, disease, height, weight and age upon the measuserrgent of body
cell mass. Groupwise comparisons were performed by ANOVA.5, S creffe.
Results: Multiple regression analysis showed that the strongest correlates with BCM were
height and weight, followed by gender; disease (AIDS), age, and env-riunent, in that order,
with an r2 = 0.86. Race had no significant effect after controlling for the other variables.
Control men weighed more and had rnore BCM and FFM than control women,. while
women had higher body fat contents. Control men and women 'wr.ited nore and had
more BCM, FFM, and fat than comparable AIDS patients.The relative proporton of weight
lost as fat and FFM (or BCM) was moderate by genden FFM accounted ir 5'%S of the difference in weight between HIV+ and control nien compared to 18 o! the difference
between HIV+ and control women.
Conclusions: The composition of weight lost due to HIV infection diffe'r in ren and
women. HIV+ women lose disproportionately more fat than HIV- ime. S i ce excess losses
of BCM and FFM in HIV+ rmen may be due to hypogonadisrn, i.e. dc eased 5testosterone,
excess losses of fat in HIV+ women could be due to hypogonadirs with:rterations in
estrogen or progesterone.
Donald P Kotles; St. Luke's/Roosevelt Hosp. Cts, 42 IWest 113th,e, Ser.ic s and
Research 1301, New York, NY I0025.Tel: [phone] Fax: (212 51 3('78
Mo.B.422
A PHASE III STUDY OF RECOMBINANT HUMAN GROWTH HORMONE
(MAMMALIAN CELL-DERIVED) IN PATIENTS WITH AIDS WASTING
Berger Daniel SI, LaMarca, A2, Landy, H3, Kauffman, RS3, Breitmeye'; jI. Center for Special
Immunology Chicago; 2Therafirst Ft. Lauderdale; 3Serono Laboraso ie, USA
Decreased body cell mass/leanr body mass is an independent prodn,,o;.ts ifact in AIDS for
early mortality and morbidity A previous Phase III clinical trial of -,t rnaliirn cell derived
recombinant human growth hormone (r -hGH[m], SerostimTM, S:ror, LsIibo rais ies, Inc.,
Norwell MA) resulted in significant weight (wgt) gain, and an even; greate ga i ir ean body
mass. A second Phase III trial was carried out to expand the clinial eperien e of rhGH[m] in people with AIDS wasting.
Methods:This 12 week study was a randomized (2:1), double blind, Placebo-controlled multicenter trial. 177 HIV positive participants who had lost 10% body 'i o who were <90th
percentile of lower limit of ideal body wgt received placebo or Set oitirrnI smg/d subcutaneously while continuing on antiretroviral and prophylactic meds.V'e i n:r.itored wgt, CD4
count, p24 Ag, HIV RNA, and quality of life with a 9 point Well-Being survey
Results: I 5 patients were randomized to r-hGH[rm] and 62 to placebo. At bIaseline for
SerostimTM and placebo respectively mean body wgt was 62.4 (+/ 8.9) and 63.7 (+/- I I)
kg; body mass index was 20.0 (+/- 2.4) and 20.0 (+/- 2.9)kg/m2; HIV assocrt'ed wt loss was
10.7 (+/- 4.71 arind I I.4 (-+/- 4. I) kg; median CD4 count was 25 (0 71)) and 34 (0-433)
cells/mm3. At 6 wks, the values were as follows respectively for SenoostirsTM nd placebo:
Mean wgt change was 2.53 (SD=3.01) and.72 kg (SD- 2.10) (p<0.00 ). At 12 wks, the
respective values were as follows: Mean wgt change was 1.6 (SD 3.089), ad.43 kg
(SD=3.26) (p=. 110).A higher than expected degree of variability, pInrnr'-ils in the placebo
group, may account for the lack of significance at I 2 weeks.The wgt charge frorn baseline in
the SerostimrTM group by paired t-test was significant at p=0.0 I. Pooled data ft-orn the 2 Ph
IlI trials showed significant wgt. gain at both 6 and 12 weeks in the S erostrn r oup. At 12
wks, change in median CD4. count was 2 cells/rnm3 and 4 cellsn c', t ir hIlV RNA
(bDNIA, log I 1Eq/ml) was 0.01 and 0.00 for the Serostim-1 and ", si ieted groups
respectively Over ill qualit of life, benefit of treatment and chanfo s' iccs is-nce improved
significantly. No change in appetite was reported.Treatment was weI i, ' ted.
Conclusions: Tieatrent of patients with AIDS wasting with Seres;e.sfted in wgt
gain and significarnt irprovernents in quality of life. hiVe observed n- deteil on of virological nor immrousoloical markers ad teatmert was well tolerated.
DS Bergen 2835 N Shefield # 104, Chicago, II 60657, USA lelep' e: i. 29.400
Fax: [phone]
Mo.B.423
A PROSPECTIVE STUDY ON THE SAFETY AND EFFECT OF NANDROLONE
DECANoATE IN HIV-POSITIVE PATIENTS
Burier. Gary-I Borge: US. Fields srdrne, Jones, R2, Reiter, S -t enI e or Special
Immunology Chicago; 21ntrex H-teathcai DfMP few Orleans; 3Crn'it ', Spi
Immunology Ft. Iaude dale
Objectives:There have beei anecdot, Ieposrts of wide anboic stero.i"ta n V p. 5ve patients
for hypogonadism, fatigue, depression, snd/or wastinrg.We repo rt the Snt run.t. 1' ial on the
safety of nandrolone decosarste (tNd) t[sDeca D rabolin, Organon) in -! v', i l t iss.

Methods: In a 12 week randomized, double-blind, placebo-controlled trial at two centers,
73 HIV-positive male patients were enrolled to receive intramuscular Nd 100 mg/week or
placebo in a 4:1 distribution respectively All subjects continued antiretroviral and prophylactic medications. At I 2 weeks (wks), all patients on placebo were given open-label Nd
for an additional 12 wks.The following were monitored: wgt, body composition by bioimpedance analysis (BIA), CBC, CD4 and CD8 cell counts, HIV - I RNA by PCR, LFT's, and
free/total testoter'one.
Results: Analysis on the first 56 (44 Nd: I 2 placebo) to complete the study are presented
here. All were homosexual males. Respective baseline characteristics for Nd and placebo
were: mean age was 34.8 and 32.8; mean CD4 counts were 395.2 (10-796) and 249. I (33 -677) cells/mme3; mean body wgt 168.3 (+/-19.2) and 155.1 (+/- 17.6) Ibs.; body mass index
was 24.5 (+/-2.8) and 22.9 (+/-2.6) kg/m2. 3 subjects withdrew due to depression, restlessness, and rnarkedly increased libido. At 6 weeks, respective mean wgt changes for Nd and
placebo treated groups were a gain of 3. I (+/- 4.3) and loss of 0.4 (+/- 4. I) Ibs (p=0.01I).
At 12 wks, mean o respective wgt gains were 3.9(+/-5.3) and 0.4 (+/- 4.3) Ibs. (p=0.04). After
12 wks, no si nificant changes were noted in both groups in LFT's, CD4 counts, or plasma
HIV load. I leimr,to rit increased a mean of 2.3% in Nd treated group and decreased mean
of 37% irn the placebo (p=0.001). Free and total testosterone levels decreased in the Nd
treated group whereas there was no changes in the placebo group. Body composition (BIA)
and other pas rieters for all 73 enrolled and the placebo crossover arm into the treatment
group are bei,g analyzed.
Conclusion: 1d therapy was safe and well tolerated in HIV-positive patients.Weekly Nd
treatment resulted in significant wgt gain after 6 and I 2 weeks, and significant increase in
hensatocril.There was no significant adverse changes in immunologic markers or HIV viral
load. Use of anabolic steroids for AIDS wasting warrants further investigation.
it Buchen 283 5 N. Sheffield #104, Chicago. IL 60657, USA Telephone: [phone]
Fax: 312 296-!097
Mo.B.424
FAT MALABSORPTION ASSESSED BY 4C-TRIOLEIN BREATH TEST IN HIV-POSITIVE
PATIENTS IN DIFFERENT STAGES OF INFECTION: IS IT AN EARLY EVENT?
HMachado Ilavia R1, Coelho, LGV2, Chausson,Y3, Greco, DB. Infectious and Parasitic
Di)seases Service.' Gastrointestinal Service2 - Federal University of Minas Gerais National
Comissio of Nuclear Energy - CDTN3, Belo Horizonte, Brazil.
Objective: Evaluaton of fat absorption in HIV+ patients, in different phases of HIV infection.
Methods: Betwveen November 1994 and February 1995,47 consecutive HIV+ individuals
on follow up at the Immunodeficiency Clinic, after informed consent, underwent a 14C-triolein breath test for evaluation of fat absorption.Ten HIV-negative healthy subjects conm
prised the constrol group (Group 1).The HIV+ subjects were separated according to the
1993 CDC revise d classification in three groups: 20 in Group 2 (AI orA2); six in Group 3
(B I or B21 and 21 in Group 4 (A3, B3 or C). Only one patient in Group 3 and two in
iroup 4 had chronic diarrhea. After an overnight fast, all individuals ingested a 30g fat meal
contain ng 5 pCi t4C-triolein.The breath excretion of 14CO2 was measured hourly for six
hours. Resut s were considered as cumulative six hours 14C excretion expressed as percentage of 4( isen as triolein and the median values of the fburr groups were compared.
Excusiot criteria included fever, obesity, diabetes, hyperlipidaemia, obstructive pulmonary
disease and hepat:c or thyroid dysfunction. Parasitic infection was evaluated through three
stool exams, including Cryptosporidium and Isosporoa investigation.
Results:The median value of 14CO2 excretion was significantly higher in Group I (8.4%)
than Group 2 (55%) or Group 4 (2.8%), p-0.039 and p=0.001, respectively Excluding the
patients with diarrhea did not affect the difference between group I and group 4
(p=0.001). Considering as normal the lowest level obtained in the control group, 52.6% of
Group 4 individuals without diarrhea had fat malabsorption.The median value of clinically
immunosuppressed patients (Group 3+4) was statistically lower than the median of Group
2 (p--0.04). Considering all subjects, CD4+ lymphocytes counts correlates with % of given
dose (p-0.000 I), but when each group was analyzed separately this correlation disap
peared. Overall, nineteen patients had eggs of parasite in their feces, but the presence of
parasit inrfection did not correlate with malabsorption.
Conclusion: Fat mnalabsorption is a common feature in advanced stages of HIV infection,
even in absence of diarrhea. HIV patients without apparent immunosuppression (Group 2)
have higher prevalence of fat malabsorption than HIV negative controls and lower than
patients with advanced HIV disease.These indings suggest that malabsorption is an early
event in HIV infected individuals and may be associated with the presence of the virus in
the gastrointestinal tract.
Flavia Machado, Av.Alfredo Balena, 190/30 andar 30130-100 Belo Horizonte, MG, Brasil
tel:[phone] Fax: [phone]
Mo.B.425
INFECTIOUS HIVVIRAL LOAD, BODY MASS INDEX AND WEIGHT CHANGE IN
IDUS AND GAY MEN
Levy. DA, rham NMH, MufIoz A., Saah AJVlahov D, Farlzadegam H., Johns Hopkins
fniersity School of Hygiene and Public Health, Baltimore, MD, USA.
Objective: to eamine the relationship between infectious viral load, and body mass index
(BMl) and weight change, and to determine if the selationship is modifed by other factors
known to be associated with weight loss.
Methods: Infecitoss HIV viral load was measured by quantitative microculture on 51 I partcpants asn wo ohort studies of Us (ALIVE) an- gay men (Baltirnore MACS).A million
PbtfI mee l's 3te six tinses at S-fold, dilutsions and 00-cultuned n the presence of PHA-P
ticte ( I on" PBMCs in a 24 well plate Cultures were fed on day 7 and p24 antigen
was rneasure.5d -- t1.e culture supernatant on day 14. Infectious units per million (IUPM) was
l~etemsnreId s ccld on number of HIV p24 pasitive (>40 pg/mI) wells in diluted cultures.To
sirsazo cl.hi t-~I data, they wene log transformed fee univarate comparisons. and rategorized is tbe exosure aria ble as follows: the reference category was zero IUPMs, and
ltne nr sisie? disln ibutron separated into thirds with values of less than 4, 4-39.9. and 40
ad ove'. B1, wei1'ht change from baseline, and weight change per year from the time of
ml, vir a ad mes iurement were modeled as corntinuous outcomes using univariate and
nnssiil ranits- I. r r 'egression.

\0
0
C
c/f
0
C
0
U
0
26