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

Mo.B.I 13 - Mo.B.117

Monday, July 8, 1996

Mo.B. 113
COMPLICATIONS IN GASTROINTESTINAL CMV DISEASE-PREVALENCE,
CHARACTERISTICS AND CLINICAL OUTCOME
Hese W,iter, Arate f K, Mostertz P Schmidt W., Biniek B, Grosse G, Lage M. AugusteVftor ia Ho ita II. Medica Clinic, berlin, Germany
Objective: 1o deter ie t: prevalence of life threatening complications such as bleeding,
per rrt on i o i,,tr ' ir Cytore'alovirus (CMV) gastrointestinal(GI) disease in AIDS.
Methods: (MV dise'iin in the CI tact was diagnosed in 257 symptomatic patients with
AIDS Ife threa i ti n pomplicalions were defined as ClGI bleeding (with the need of urgent
endoC pi), inite- iina! peri iin (diagnosed by surgery) and intestinal obstruction (presertn ' wth act, habdoiriinal pn). Frez lence, risk factors (incl. CD4 cell count), localization an l i alo.tcome were doicrnented and compared with patients with uncomplicated cini l ourse in CMV disease ( roup I).

(p<0.001).The choice of PCP prophylaxis did not significrntly influence tr
infection. b) EB was detected in the stool of 15 pts. using the calcofluor ethod.T w
confirmed by EM and/or trichrome in only II pts. 10 oi the II pts. had du
biopsies were positive in 3 pts., duodenal!avage fluid in 2 pts. only Microspord _ i
detected in biopsies or duodenal lavage fluid of any patient who did rioIt iso a -
in stool. No evidence of disseminated disease was detected in r int't
EB infection.
Conclusions: Intestinal microsporidiosis is highly prevlent,rnd! t o r rttut rrpc
the most common cause of diarrhea. Stool samples have i higher ield h r ii
sies. Calcofluor staining facilitates the rapid screening of multiple sinpr,i d,
diagnostic method. Because it lacks specificity howevenr pc tive sanmples r(d to, r
firmed with specific methods (modified trichrome stain or EM). Especii al in,, wth )
served CD4 cell counts self limited microsporidiosis occu s. Asymptonr tit cre:,,
constitute an important natural reservoir of EB.

hB

fl 1
I
0
0rt

Results: I Ife thr n tenii
artr oirtestnlIC( MV
pAt.). A:ge, ri behevic
were r ll 1owel ors i
GI tilcrik hI:] i-)pr
l rTttc, anti (CMV ith
differ r bIr eizi n tiei
Conclusions: (ormpi
(MV diiease (I.

complications were found in 31/257 AIDS patients (group II) with
ease (peforition inr I I pat., bleeding in 12 pat. and obstruction 8
AIDS at diagnosis were similar in both groups, while CD4 cells
i;)t. with romrplikation (30/ul vs. 52/ul). Main sites of perforation
e reion, where also most obstructions were observed, while
Sosin; oclizition Sur gery was necessary in 9 cases, while symppy r injection therapy was done in 22 pat. Survival time did not
l th (8.2 months) ind without complication (7.2 months).
eI CMV courses in GI disease aire frequent findings in pat. with GI
or tion and obstruction are mainly observed in the small bowel or
r ( 1 i >1phtions do not influence survival time due to antiviral regIp) ndyrnptorriati or surgical therapy.
i, ospitrl, Rubenssti: 125, 12 157 Berlin, GermanyTel.: 0049 30 -790 )00,its
trf

th(' C r i'.1 I i eirc, ierl
ir r u (I r l ( I lov ito"( itaf
W Hei<,, Aug alc Vikcor
790 '32 I x: 9 I

Dr med. H. Albrecht, UK Eppendorf Pav. 33 Infe, Martinistr: 52, 2024i6 Ir r,,'
Tel: xx49 -40 47172831, Fax: xx49-40-47 175187, e mail iarer ta eun,,r l.d.
Mo.B. I 16
ITRACONAZOLE ORAL SOLUTION (IS) COMPARED WITH FLUCONAZOLE (F)
FOR TREATMENT OF ESOPHAGEAL CANDIDIASIS (EC)
Moskovitz, Bruce L*,Wilcox CM*'", Darouiche R'", Wu ij, McleCol I nsre,,i 1 -Foundation,Titusville, NJ: "Emory U. Sch Med, Atlanta: *-'VAI('I u u:i. rX.
Objective:To demonstrate comparable safety and equivaeiit efic(ofIS, i l ccIr:xr
formulation with greater bioavailability than itrirna zole,rpsa i. to F t' i- r'rn?
in immunocompromised patients.
Methods:This was a double-blind, double-dummy study Fe err '
to IS or F, 100-200 mg dailyTreatment continued for 2 weeks be'ik pr....:r ci0,
toms, with a minimum of 3, but no more than 8 weeks. Evilutiois wee we ir v I '
treatment and every 2 weeks during a 28-day follow up foI re'rpse Pert snwree,
as ''cured" (clear all signs/symptoms), "improved (substantiamprovement), or "id
imal improvement, no change, or worse)."Resaonse" = c red + mproved. A rncca
assessment based on an end-of therapy endoscopy determined 'e-,di tan" (rr r
culture negative) or "persistence" (lesions and culture poitive). The sanupsDze. (
lated to ensure 80% power and 0.05 level in demon str t r' equirlec i.r ) ISit
equivalent if the 955 confidence interval (CI) for the difference (IS- -in rcpo sa '
within the range 0.20 to 0.20.

Mo.B.I 14
CLINICAL MANIFESTATIONS, EXTRAINTESTINAL COMPLICATIONS AND LONGTERM COURSE OF INTESTINAL ENTEROCYTOZOON BIENEUSI MICROSPORIDIOSIS
Briner, l)r i', Mster th, I thy R*, Weber R, and the Swiss HIV Cohort Study (SHCS).
"tn i'rs tp IIn o'lof Z hc Shfwitzerland; and University Hospitals of Basle, Berne,
Gerv, Lau,r irc
Objective: To rdetei rmine the c ria manifestiations, complications, and the long term course
of F. bifes',, irflectiern.
Methods: HIV + patient, (5 women, 50 nren) with E. b ieneusi-infection were studied.
P tents we prspect Cly followed in the ongoing Swiss HIV cohort study (SHCS) which
Slded the uevltr ' of patients with diarrhea since July 1992. Microsporidia were detectecd by r ro,iopKx~rrit or tof hromrotrope stained stool, urine, sputum, and bronto1vrolar fl d e i s. Identifiotion of r.. ienustr was based upon electron microscop
il exairinaion. Ar,rc' SI St r centroprodignosis to detect microsporidia was also
doris:' 851 r,,ccutr'atient without diarrhea.
Results: At trime f diagnosis o F. bemusi -infection, the median CD4 cell count was
sIn(ran ( i 0 -190;6r'a5% '5-0, 9.1% > i200/mm3). Patients were followed for a median
of 10. I rnor t, c i85). i hree. asymptomatic E. bieneusi carriers were identfied irron the 81tper on w 'ithout diarrher. One paient remained asymptomatic
((C D4 -90). two developed di rrhe< during follow-up (CD4-81, 180). Of the 52 patients
with dIir hei ist tmeof dagnosisr, 38.5% had persistent chronic diarrhea (median CD4
2/rn;range 120), 44.2% had chronic intermittent diarrhea (median CD4 20/mm3;
range 0 300), and I /.a ecanime isymptomatic (median CD4 II 8/mm3; range-30-300)
ut continued to excrete rncrospondial spores in stool. Extraintestinal complications of E.
enev infection we e: hlnsiopithy (56.4%), acalculous cholecystitis (5.5%), and respiratory tact ii:f-ct i )i.5,). E r Ct si was not detected in urine. 32/55 (58%) patients died,
/ 12 due to 'ever e ciepr oba ily related to E. bieneusi infection.The 1--year survival
was 52.8% (95 confidenicr intervals 38.6 67.0), the 2-year survival 26.9% (95% Cl, 11.7 -42.1; Kaplani Mecr rethod). 0. O% of the patients had dual/multiple intestinal nfection(s),
29. % i tine of diano of E./,iusi-infection, another 21.8% during follow-up.Survival
of pairnts with,t writho t intestnal coirifections was similar.Treatment with albendazole
did neit ra lter n asite excretion nor outcome.
Conclusions: K urnus infection wais associated with chronic diarrhea. Observed extrainti ti ist r l ic i tons were bibiry rand respiratory tract infections. E. beneusi infection itself
was not imedi ietly lie t 'rearning and Iong termn survival of more than three years was
ur', isved yevrthel, 'deabth due to severe wasting syndrome (probably related to intestinal ni r idio cs) air: ron mn. Treatment did neither eradicate the parasites nor
irpiove sur vival.
Raine WenM:. )., iv rton of Infec ious Diseases, University Hospital, CH-8091 Zurich,
Switveiland;]-el: "i I H55 I I1:Fix: 41 I 255 32 9
Mo. B. I 15
PROSPECTIVE EVALUATION OF THE CLINICAL SIGNIFICANCE OF INTESTINAL
MICROSPORIDIOSIS IN 2 COHORTS OF HIV-INFECTED PATIENTS
Albrechtl Ic lmit, Sohttka I, Zelrnainn M. Meyer 5. Jlickle 5, Stellbrink HJ, Greten H.
niverritp (lin( hppendorf, HamrIburg, Germany
Objective: determrine the cinical signficance of intestinal microsporidiosis in two differ
eni coIorts of V infected patients and to compare the sensitivity and specificity of differen dia n,ticm ethod.
Methods: lwo pr opete s tudi swere performed: a) Between November 1993 and
Septemer 1994,tool iaples f 97 consecutive patient (pts.), 50 with diarrhea, were
examined for vr iety of ente ic pathogens. b) Stool samples, duodenal lavage fluid, duodeInal ops e c onjcival swabs,. une, sputum, nasal secretions of 64 consecutive eligible pts.
(39 wifth d airrhea rndergoing esophapo gastro duodenoscopy between September 1994
ind Agust '995 wer Ce analysed for the presence of nicrosporidi using different staining
r hn i ra i n 1 c: it rc n ii c )opy (EM ).
Results: a) In 8 of I7 pt. i Ferocytozoon bieneusi (FB) and in 2 Septata intestinals was
ldete d i ti r, i <, r l c, 18 ftI ph, lis. d diarrhea. Concomitant intestinal pathogens

Treatment
IS
F

Cured Response[ Er dic it on
48/53 (91%) 50/53 (94%)4 4/19 (C 2C tr#
49/57 (86%) 52/57 (9 I%) 40; '8

tPrimary parameter;: #95% CI for difference=(- 0.065, 0.127); ##95% (-0002,2
Three IS and 3 F patients discontinued for,ain adverse everit.
Conclusions: IS is as effective as F for patients with LC. Both r s re.,ell oler itd
B.L Moskovitz, Janssen Research Foundaition, I 25 TrentriHi arbourton Rd, Ltu le, j
08560 Telephone: [phone] FAX: [phone]
Mo.B. I 17
ITRACONAZOLE ORAL SOLUTION (IS) FOR THE TREATMENT OF OROPHARYNGEAL
CANDIDIASIS (OC): RESULTS OF TWO RANDOMIZED, BLINDED STUDIES
RO Darouiche*, JR Graybill**, J Vazquez***, P Murray ''" J W. '"kB,<,tz...
*VAMC, Houston,TX; *UTHSC, San Antonio,TX; '* Vayne riS eir1ta [ t
"**UMDNJ, Newark, NJ; ** "*Janssen Research Foundion. Tituslle.NJ
Objective: To compare the safety and efficacy of IS (cycldextri: forrnl,ton wt clotI
mazole (C) and fluconazole (F) in HIV + patients (pt) wihIP.
Patients: Study I (IS vs C) = 162 total pts enrolled. I 34 H1IV + enr r-ol i 3 I ll '
ated; Study 2 (IS vs F) = 190 HIV + pts enrolled, 179 ev ilut Ii t, r r', - h1-:, d,:1
OC confirmed by KOH and culture.
Methods: Study I -=: I randomization to IS (200 m/d) r c 0 mk t am,'d for,
days. Study 2- =I1:1 randomization to IS (200 mg/d x 7 days), IS 0 '. i,
F (100 mg/d x 14 days). Evaluations at end oftherapy and for 28 day u pi
Clinical response (global evaluation of"cured" or 'rmproved"), m lo, ' eA r <
CFU/mL mouthwashing), overall response (clinical + my oo it r's e5dnespos t e siia,:
Conclude superiority if difference in response rite was rit f rlly '.ii ml - (
power=0.80. Study 2: Conclude equivalence if confident- li oi,n: '
rates were within + 20% at alpha=0.05, power 0.80: cofide':c'i -i.
to adjust for 2 comparisons. All tests were two tailed.
Results:
Study I '
Response IS C p IS 7 IS I
Clinical 77% 66% 0.18 83%
Mycological 66% 47% 0.04 5
Overall 55% 36% 0.04 43% 88/ /
*For IS -14 vs. F for 14 days
Conclusions: Systemic therapy of OC with IS is at least, rl,fe,- &,ind1,,.l
tolerated for the treatment of OC in HIV + pts.
RO DarouicheVA Medical Center, 2002 Holcombe Bou rl:rd Hotor,. 5X '?Telephone: [phone] Fax: [phone]

W(It (.

> t i, ' lpts. with drrhea. In summary microsporidia
ref ih,;::,t '. 'i un -,i aid ird 1.3: of the asrymptomati( pts.

17