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

316 Abstracts 22268-22272

12th World AIDS Conference

traditional treatment) gave written informed consent. Results were analysed
through EPI INFO 6.0 software (CDC 1994).
Results: 12 patients were included: 6 (50%) were allocated to the single daily
dose arm; 10/12 (83.8%) were male. Mean age was 35.75 (std.dev.:11.5) -range
20-58. Other previous or associated opportunistic infections had occurred or were
present at time of CW diangosis in 11/12 (91.7%). CW retinitis was diagnosed
in 58.3% (7/12) and esophagitis in 41.A (5/12). 91.7% of the patients treated
with either modality had a good response to treatment. The only side-effect
was leucopenia (50%) resulting in interruption of treatment in 3 occasions, dose
reduction in 2 and administration of granulocyte-colony-stimulating factor in 2.
Three patients died, apparently of causes unrelated to CMV. No relapses were
observed up to december 97.
Conclusion: Induction treatment with single daily dosing ganciclovir presented
no significant differences as to efficacy and frequency of relapses and side-effects,
compared to traditional twice daily dosing. More patients should be studied for
better significance and, ideally serum ganciclovir levels should be monitored in
this promising modality of treatment for CMV disease.
22268 1 Long-lasting remission of CMV retinitis without specific
CMV maintenance therapy after initiation of HAART in 4
AIDS patients
Thomas Lutz1, T. Stark1, P. Gute1, V. Miller1, H. Guempel2, S. Staszewski1,
E. Helm1. 1Dept. Inf. Dis. JW Goethe-University, Frankfurt/Main, Germany;
2Dept. of Ophthal. JW Goethe - University Frankfurt/Main, Germany
Background: Active CMV disease causes significant morbidity and mortality in
AIDS patients. CMV-Retinitis (CMV-R) is still the most common manifestation
of CMV disease in these patients. A number of effective local and systemic
treatments are currently available. Recent studies have shown a decrease in
incidence of CMV-R in patients on HAART. Additionally, there is now growing
evidence that long lasting remission of CMV-R may be possible without CMV
specific maintenance therapy.
Objective: Clinical and virological analysis of 4 AIDS patients with CMV-R
(diagnosed between 3/95 and 8/96).
Patients: 4 (1 woman, 3 men) severely immunocompromised AIDS patients
(CD4 cells 1-12/pl) with long-lasting remission of CMV-R under HAART. All
patients discontinued CMV specific maintenance therapy. Observation time is
between 18 and 24 months. In all patients, significant increases in CD4 count
and HIV-1 RNA reductions to < 500 copies/ml were observed under HAART.
Case reports: case 1: CMV-R diagnosis (dx): 03/95. HAART started 01/96.
Cont. ganciclovir treatment until 09/96, when explantation of infected central
venous catheter was required. CMV-maintenance therapy was not resumed; Patient remains relapse-free for >16 months. case 2: CMV-R dx: 10/95; HAART
started 01/96. Ganciclovir induction therapy, followed by pellet implantation in
affected eye. No systemic CMV-specific therapy was initiated, and the pellet was
not exchanged. Patient remains relapse-free for >26 months. case 3: CMV-R
dx: 08/96. HAART was initiated 07/96. Cont. ganciclovir until 05/97. No CMVrelapse for >7 months in the absence of CMV-specific therapy was observed.
case 4: CMV-R dx: 10/95. Patient experienced two relapses (12/95, 03/96) under
conventional CMV-maintenance therapy which was administered continuously
until 09/97, when explantation of infected central venous catheter was required.
Oral ganciclovir was given for two months and discontinued 11/97. Patient has
remained relapse free for >2 months without CMV-specific therapy.
Conclusion: These 4 AIDS patients with CMV-R on HAART have not relapsed
after follow up periods of up to 26 month, even without anti-CMV maintenace
therapy. The hypothesis is that potent antiretroviral therapy including protease
inhibitors restored some degree of CMV specific immunity in these patients. The
role of HAART in the prevention and therapy of CMV-R should be explored further.
S22269 Impact of indinavir (protease inhibitor) on HCV viral load
in patients coinfected with HCV-HIV
Odile Bouchard1, G. Gavazzi2, P. Leclercq2, P. Morand3, A. Bosseray2,
J.M. Seignevrin3. 1Service de Maladies Infectieuses, Chu Michallon, 38043
Grenoble; 2lnfectious Diseases Department, Grenoble; 3 Virology Department,
Grenoble, France
The co-infection with hepatitis C virus (HCV) and Human Immunodeficiency Virus
(HIV) accelerate the evolution of the HCV infection. The aim of this study was to
compare HCV viral load evolution between two groups of patients. 30 patients
co-infected with HCV-HIV were followed prospectively, all justified an antiretroviral
therapy:
Group 1: 15 patients received 2 nucleoside inhibitors of reverse transcriptase,
group 2:15 patients received 2 nucleoside inhibitors of reverse transcriptase and
indinavir (protease inhibitor).
HIV viral load, HCV viral load, CD4 counts and transaminase levels (ALT
and AST) were measured before the introduction of the therapy and after three
months.
In group 1:

- before the therapy: HCV viral load was 4.69 log, HIV viral load was 4.03 log,
CD4 counts were 182/mm3, AST and ALT levels were respectely 70 UI and 64
UI.
- after three months of therapy: HCV viral load was 4.91 log (A log = +0.22),
HIV viral load was 3 log (A log HIV = 1.03), CD4 counts were 229/mm3 (A CD4 =
+47), AST and ALT levels were respectely 71 UI and 54 UI (A AST = +1, A ALT
= -10).

In group 2:
- before the therapy: HCV viral load was 4.42 log. HIV viral load was 5.01 log,
CD4 counts were 150/mm3, AST and ALT levels were respectively 81 UI and 57
UI.
- after three months of therapy: HCV viral load was 4.85 log (A log = +0.43),
HIV viral load was 3.1 log (Alog HIV = -2), CD4 counts were 261/mm3 (A CD4
= +115), AST and ALT levels were respectely 102 UI and 92 UI (A AST = +21, A
ALT = +35).
In the patients co-infected with HCV-HIV, the antiretroviral therapy with or without indinavir didn't modified significatively HCV viral load, AST and ALT levels in
spite of the decrease of HIV viral load and the increase of CD4 counts.
122270 1 Oral ganciclovir (GCV) for maintenance therapy of
cytomegalovirus (CMV) retinitis: Experience from the
European Compassionate Use Programme
Marianne Walker, M. Popescu. F Hoffmann-La Roshe, Grenzacherstrasse 124,
CH - 4070, Basel, Switzerland
Objectves: To describe the safety of oral GCV in HIV-positive subjects with
ophthalmologically stable CMV retinitis and with limited venous access, and to
describe the time to retinitis progression from the start of oral GCV maintenance
therapy.
Design: Open-label safety program.
Methods: All patients had received either intravenous GCV or foscarnet over
at least 18 of the previous 21 days before study start. The mean duration of oral
GCV treatment (3 g daily, 1 g tid) was 117 days (range 0-635 days). 56% of
patients were also on antiretroviral therapy, and of those only 11% were receiving
a proteinase inhibitor.
Results: A total of 315 patients were enrolled between January 1994 and
October 1996. Adverse events reported most frequently related to the gastrointestinal system and were mainly mild to moderate: diarrhoea (17%), nausea
(10%) and vomiting (10%). Neutropenia, defined as an absolute neutrophil count
<500 cells/[tL, occurred in 2% of patients. Use of colony stimulating factors was
reported for 22% of patients. The frequency of anaemia (minimal haemoglobin
<8.0 g/dL) and thrombocytopenia (platelets count <25,000//pL) were reported
for 5% and 1% of patients, respectively. The incidence of sepsis was 8% in this
patient population. Disease progression, as assessed by study site ophthalmologists using funduscopy, was observed in 125 patients (40.7%) with a mean time
to first noted progression of CMV retinitis of 221 days (SEM: 18.1) and median
time to progression of 122 days (95% CI: 93-186).
Conclusions: Oral GCV at a daily dose of 3 g is well tolerated. The safety and
efficacy data collected in clinical practice were comparable to those presented in
controlled clinical studies.
22271 Nonprogression of CMV retinitis in AIDS patients on
highly active antirretroviral treatment (HAART)
Gabriela Ortega-Larrocea1, Juan Sierra-Madero2, D. Carranza-Salazar2.
1Puente De Piedra 150-523, Tlalpan 14050; 2 nstituto Nacional Nutricion,
Mexico, DF, Mexico
Objectives: To describe seven cases of citomegalovirus retinitis (CMVR) in AIDS
patients on HAART and without progression of retinitis after stropping ganciclovir
(gcv) maintenance therapy.
Patients and Methods: Seven patients with AIDS and CMVR were treated
with three drug potent antiviral regimens including at least one protease inhibitor
and gcv induction therapy. When gcv maintenance was stopped, mainly for economic reason (24-72 week duration) retinitis was inactive in all patients. Regular
periodic fundoscopic exams were performed.
Results: Follow-up after stopping therapy was from 3 to 17 months. One patient
was lost to follow-up at 3 months. No CMV progression has been documented in
any patient. CD4+ T lymphocyte count increased to 75, 268, 153 and 110 in four
patients in whom they were measured.
Conclusions: HAART in AIDS patients with CMVR may reduce the risk of reactivation disease. Studies are needed to define risk factors of CMVR progression
in AIDS patients on HAART.
[22272 | HLA class I antigens and class II alleles in Brazilian AIDS
patients with cytomegalovirus retinitis (CMV-R)
Maria De Lourdes Veronese Rodrigues1, J.F.C. De Castro Figueiredo2,
E.A. Mabtum3, N.H.S. Deghaide4, N. Vieira De Souza2, E. Romao2,
E.A. Donadi2. 1Tamaoios 262-ap. 101, 14020-700 Ribeirao Preto; 2Faculty of
Medicine-USFR Ribeirao Preto, SP; 3Faculty of Medicine-USP Hospital Clinic,
Ribeirao Preto, SP; 4 Hospital Das Clinicas, Ribeira Preto, SP Brasil
Objectives: To analyse HLA class I and class II specificity frequencies in AIDS
patients with CMV-R.
Design: Observational, transversal and analytical study.

Method: A total of 16 AIDS patients (14 males) aged 26-41 years (median
= 31.5) with CMV-R and 423 healthy HIV negative controls from the some geographic region and similar ethnic background were studied. The diagnosis of
CMV-R was performed on clinical basis, using binocular indirect ophthalmoscopy.
HLA typing for class I antigens was performed using a complement-dependent
microlymphocytotoxicity assay, and class II alleles were determined by polymerase chain reaction-sequence specific probe analysis. Statistical analysis was