Bridging the Gap: Conference Record [Abstract book, International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

542 Abstracts 32106-32111

12th World AIDS Conference

much higher prevalence than in other African countries; 3) Cotrimoxazole as the
initial treatment of bacterial enteropathogens, as suggested in the WHO guidelines, is not valid for Rwanda; 4) Our findings may be useful to design relevant
guidelines for the management of CD among HIV- infected adults in Rwanda.
32106 SP-303: A new treatment for AIDS-associated diarrhea
Mark Holodniy1, J. Koch2, M. Mistal1, J. Maimares Schmidt2, P. O'Hanley1,
S. Porter3. 1AIDS Research Center (VAPAHCS) 3801 Miranda (119) Palo Alto,
CA 94304; 2U.C. San Francisco, San Francisco, CA; 3Shaman Pharmaceuticals,
San Francisco, CA, USA
Objective: A phase II, randomized, double blind, placebo controlled study to
determine the safety and efficacy of orally administered SP-303 (an extract from
a naturally occurring product) in HIV infected subjects with AIDS and chronic
diarrhea.
Methods: Subjects with a history of a CD4 cell count <200/mm3 or an AIDS
defining illness were admitted to an inpatient study unit and screened for diarrhea defined as >3 unformed stools/24 h and >200 g of stool/24 h. Subjects
discontinued all antidiarrheal agents >24 h prior to enrollment, but continued all
other medications. Stool samples were studied for routine pathogens. Subjects
then received 500 mg orally of SP-303 or placebo every 6 hours for 96 hours (4
days). Subjects were monitored for abdominal symptoms and side effects. Stool
frequency and weight were recorded. Safety laboratory data was also obtained.
Subjects were seen one week later in followup.
Results: There were no significant differences between the treatment arms
with respect to age, race, past medical history, CD4 count or viral load. 51
subjects (49 men, 2 women) qualified (26 received SP-303, 25 placebo). Stool
studies revealed no pathogens in 48/51 (94.1%) [C.difficile (2), cryptosporidium
(1)]. 44/51 subjects were receiving protease inhibitor (PI) containing regimens.
There were no serious adverse events or laboratory abnormalities associated with
SP-303 or placebo administration. The SP-303 treatment group demonstrated a
mean reduction from baseline stool weight of 451 g/24 h vs. 150 g/24 h with
placebo (p =.14). Abnormal stool frequency decreased from a mean baseline of
5.2 to 2.2/24 h after SP-303 vs. a reduction from 5.2 to 3.1 in the placebo group
(p =.26). Random regression analysis over 4 d of treatment demonstrated that
subjects treated with SP-303 had a significant reduction in stool weight (p =.008)
and frequency (p =.04) when compared to those treated with placebo.
Conclusions: SP-303 appears safe and well tolerated. The majority of subjects
with AIDS associated diarrhea do not have identifiable pathogens. Our results
suggest that SP-303 may be effective in reducing stool weight and frequency
associated with AIDS diarrhea.
32107 Effect of HIV-infection on hepatitis C virus
(HCV)-infection in hemophiliacs and i.v. drug users
Jurgen Rockstroh1, U. Spengler2, R. Kaiser2, 0. Loch3, B. Helm4, O. Degen5,
K. Schlifer2. 1Medizinische Universitatsklinik, Sigmund-Freud-Str. 25, 53105,
Bonn; 2Dept. of Medicine, University of Bonn, Bonn; 3Dept. of Medicine,
University of Munich, Munich; 4Dept. of Medicine, University of Frankfurt,
Frankfurt; 5Dept. of Medicine, University of Hamburg, Hamburg, Germany
Objective: To clarify the interactions between HCV- and HIV-infection in 61
HIV-/HCV-double-infected hemophiliacs and 291 double-infected i.v. drug users.
Methods: At baseline and after 6 months HCV-RNA-Levels were determined
quantitatively by the Roche Monitor PCR-assay in a central laboratory. HIV-RNA
was measured in each participating center either by NASBA, Roche-PCR or Chiron bDNA, respectively. CD4+-/CD8+-counts, aminotransferases, cholinesterase,
alkaline phosphatase, and bilirubin were determined by routine procedures. All
patients were characterized with respect to possible HGV-coinfection (HGV-PCR)
and HCV-genotype.
Results: At baseline, only a weak correlation between HIV-RNA and HCV-RNA
was detected in the hemophiliac subgroup (r = 0.339; p < 0.05). In both patient
groups no correlation was found between CD4-counts and HCV-RNA. After 6
months of follow-up an inverse trend was observed between the difference in
CD4-count and the decrease in HIV and HCV viral load, respectively (r = -0.101
and r = -0.115). A higher rate of mixed infections with several HCV genotypes was observed in HIV-/HCV-coinfected hemophiliacs versus i.v. drug users
(21% vs 13%). In contrast, HIV-/HCV-coinfected drug abusers had significantly
more frequent HGV-coinfections than hemophiliacs (odds ratio 3.414; 95% Cl
1.124-10.366).
Conclusion: In hemophiliacs higher HIV-levels correlate with higher HCVRNA-levels at baseline. However, declining CD4-counts as a surrogate marker of
deteriorated immune function were not associated with higher HCV-RNA-levels
at baseline. However, after 6 months of follow-up, a decline in CD4-counts was
paralelled by a rise in HCV-RNA.
S32109 Prevalence of helicobacter pylori infection in HIV-infected
patients

Franqois Bissuel1, L. Cotte2, D. Pere-Verge2, F. Bailly2, M. De Monclos3,
D. Vitrey2, C. Trepo2. 1Liver and AIDS Unit, Hotel-Dieu Hospital 69288 Lyon
Cedex 02; 2Hotel-Dieu Hospital, Lyon; 3Lyon-Sud Hospital, Lyon, France
Objective: To evaluate the prevalence of Helicobacter pylori (HP) in HIV-infected
patients, which is a major etiologic agent of upper gastrointestinal symptoms in
HIV-negative individuals.

Methods: From July 1994 to May 1996, we conducted a prospective study
in HIV-infected patients who underwent upper endoscopy in our unit. Antral and
duodenal biopsies were systematically performed. HP infection was diagnosed by
identification of the organism on histology (Giemsa staining), culture, or positive
urease testing (CLO-test).
Results: 81 patients were studied (73 male, 8 female): 38 homosexuals, 15
intravenous drug addicts, 14 heterosexuals, 2 blood transfused. 63 patients belong to CDC stage C. Mean CD4 count was 92/mm3 (0-928). 45 patients had an
antiretroviral therapy including one or two nucleoside analogues.
Endoscopy was performed within a context of diarrhea in 26 patients, weight
loss in 22, dysphagia in 16, abdominal pain in 15, and anorexia in 2.
A total of 27 patients (33%) were positive for HP (HP+).
Endoscopy was macroscopicaly and histologicaly abnormal in 70 patients:
gastric ulcer or gastritis in 46 patients (21 HP+), duodenal ulcer or duodenitis
in 35 patients (11 HP+), esophageal candidiasis in 28 patients (13 HP+), peptic
esophagitis in 3 patients (0 HP+), Kaposi's sarcoma in 6 patients (4 HP+). 11
patients presented with normal findings (1 HP+).
Conclusion: The prevalence of HP in upper gastrointestinal biopsies is the
same in the studied population (33%) as in the general french population (30%).
The frequency of HP infection is lower in HIV-infected patients than in HIV negative patients who suffered from gastritis or gastric ulcer (45% vs 70-90%), and
duodenitis or duodenal ulcer (31% vs 90%). In our study, no correlation was found
between HP+ and sex, HIV risk factor, CD4 count, and antiretroviral therapy.
32110 1 Clinical manifestations of mycobacterial enteric infection
in patients with AIDS
M. Corti, Jorge N. Velasquez, S. Carnevale, C. Di Rissio, A. Chertcoff,
M.G. Cabrera, M.E. Pinto. Hospital "Dr. Francisco J. Munlz", Buenos Aires,
Argentina
Objectives: To describe the clinical features of AIDS patients with mycobacterial
infection affecting the gastrointestinal tract.
Methods: This study enrolled 156 adult patients with digestive symptoms and
AIDS. The examination of feces included iodine trichrome blue and acid-fast
preparations of direct and concentrated samples. We carried out videoesophagogastroduodenoscopy (VEDA) to visually inspect the mucosa and obtain biopsy
specimens. They were stained with hematoxylin-eosin, Giemsa, Azur II and acidfast. In patients with presumable mycobacterial disease, thorax radiography and
sputum examination or hemoculture were performed.
Results: Among of the 156 patients enrolled in this study, six individuals presented mycobacterial infection of gastrointestinal tract. The average age of the
subjects was 29 years (range = 22-36) and the mean CD4 cell count was 151
cells/mm3. All patients were intravenous drug abusers. In three patients, infections due to Mycobacterium avium intracellulare (MAC) were identified. Abdominal
pain was present in these patients and there was one case with diarrhea. VEDA
revealed mucosa changes in all cases. Hemoculture was positive for MAC and
duodenal biopsy specimens showed bacilli. In feces, bacilli were detected in two
patients. The other three cases were diagnosed as Mycobacterium tuberculosis
(MT). Disphagia, cough when eating and diarrhea were present in two cases,
showing esophagus fistula and duodenal mucosa changes in VEDA and hiliar
adenomegaly in thorax radiography. The third patient had cough, abdominal pain
and chronic diarrhea, with chest radiography showing diffuse bilateral infiltrates.
The VEDA of this case revealed abnormal duodenal mucosa; the duodenal
histology showed bacilli and culture of sputum was positive for MT.
Conclusion: Enteric infections with MAC are well known but MT is another
opportunistic pathogen that can be detected in patients with AIDS and gastrointestinal symptoms.
S32111 No difference in HCV viraemia between HIV positive and
negative subjects and absence of increase in ALT values
and HCV-RNA by use of protease inhibitors
Giovanni Carlo Fibbia1, M. Gomma2, O. Bosco2, U. Galvan2, M. Mazzi2,
G. Serpelloni2. 1 Via Germania 20 37135 Verona; 2Sezione Screening HIV-ULS
20 Verona, Italy
Objectives: 1) To evaluate the prevalence and the viraemia (logiocopies/ml) of
HCV in HIV positive and negative patients; 2) to compare the effect of protease
inhibitors (PIs) on the HCV viraemia and ALT values in the HIV positive subjects.
Methods: All the patients who resulted positive for HCV antibody by EIA were
tested for HCV-RNA by RT-PCR method; the HCV-RNA was qualitative and if positive the genotype and the quantitative viraemia (loglo copies/ml) were evaluated.
HIV infection was determined by EIA and if positive it was confirmed by Western
Blot analysis. All HIV positive patients had been taking antiretroviral therapy (10
pts double and 9 pts triple combination therapy) for more than 3 months.
Results: Forty-nine patients were tested for HCV RNA: 29 were HIV negative
and 20 HIV positive. The HCV-RNA resulted positive in 39 pts and negative in 10
pts; 1 pt (HIV negative) had no HCV genotype and viraemia determination. Of the
20 HIV positive pts, 19 (95%) resulted HCV-RNA positive and 1 (5%) negative; of

the 29 HIV negative pts, 20 (69%) were HCV-RNA positive and 9 (31%) negative.
The HCV viraemia in subjects with HIV infection was of 6.10 logio copies/ml, while
in HIV negative pts it was of 5.7 logio copies/ml (not statistically significant-NS).
Furthemore, the HCV viraemia was of 6.29 loglo copies/ml in the HIV+ pts with
PIs therapy and of 5.70 logio copies/mi (NS) in 10 HIV+ pts without PIs. The ALT
values were of 126 UI/I and 85 UI/1 (NS) respectively in those with PIs and no
Pis containing regimen.