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

12th World AIDS Conference

Abstracts 32244-32248 569

S32244 Intravitreal followed by oral ganciclovir (GCV) as an
option for the treatment of cytomegalovirus retinitis
(CMV-R) in a day care health center (DCHC)
Martin Meerhoff1 2, A. Tondo2, G. de Feo2, E. Savio2, M. Lowinger2,
C. Mogdasi3. 1S.E.I.C., Hosp. Dia., H. Irigoyen 1403 Ap. 704, Montevideo
11400; 2AS. Espaiola, Montevideo, Uruguay
Background: The incidence of CMV-R as a complication of HIV infection has
diminished with the administration of highly active antiretroviral therapy (HAART).
Nevertheless, cases of CMV-R are still reported even with this therapy. The
importance of CMV-R lies in the subsequent visual disability of the patient and
in the economic impact it has on health care costs. In DCHC for HIV Infected
People we began to apply a diagnostic-therapeutic protocol to treat CMV-R under
good technical conditions and with reasonable costs. This protocol included the
first GCV intravitreal injection administered in Uruguay.
Methods: 90 patients were referred to DCHC for ophthalmological examination
between 06/96 and 11/97. The diagnosis of CMV-R was based on ophthalmoscopic findings. Patients with CMV-R received the following treatment: intravitreal
injections of GCV (4 mg in 0.1 cc) twice a week for 2 weeks, followed by oral
GCV 3 g/day indefinitely. During the first month this treatment costs US$ 1.175
compared with the standard treatment with intravenous GCV followed by oral
GCV maintenance which costs US$ 2.064.
Results: CMV-R was diagnosed in 5 patients. 3 of them were referred to DCHC
for treatment. All of them were male. Their ages were 33, 30 and 43 years old.
Their T4 counts were 210, 90 and 341/mm3 respectively. The viral loads of the
2nd and 3rd patients were 1 million and 13.500 cop. ARN/ml respectively. The
first 2 patients were under treatment with 2 Transcriptase Reverse Inhibitors +
1 Proteinase Inhibitor. The 3rd patient was not under antiretroviral therapy. The
ophthalmoscopic findings were mainly: soft exudates and haemorrages along the
vascular arcades. The 3rd patient was not included in this trial because treatment
was not completed as stated in our protocol. In 2 patients complete remission of
CMV-R was obtained. Both are still on maintenance therapy with oral GCV with
a good tolerance and no side effects after 3 months of treatment.
Conclusions: Even under HAART CMV-R is a complication that must be
searched for. Treatment with intravitreal GCV followed by oral GCV maintenance
therapy is probably adequate considering results and cost-benefit and it is easily
applied in a DCHC. The continuity of this study will allow us to reach more
definitive conclusions.
32245 1 The viral diseases of anterior segment of the eye in
HIV-infected patients
Vasily Shakhgildian1, Nikolay Marchenko2, A.V. Kravtchenko2. 1Research
Institute Ofeye Diseases, Moscow; 2Russia Federal AIDS Center, Moscow,
Russia
Objective: To determine the frequency and nature of ocular complications in
HIV-positive patients (pts.).
Patients and Methods: 290 HIV-positive adult pts. (100 persons with AIDS)
were observed in 1993-1997. The active CMV infection was approved by detection of moderate or high level of DNA CMV in blood cells by PCR; HSV
and adenoviral infection - by direct fluorescent antibody test in the conjunctival
smear. The ophthalmic investigation (the visual testing, biomycroscopy, indirect
ophtalmoscopy) was accomplished one time in 2-12 weeks.
Results: In all 15 pts. with CMV-retinitis (approved by PCR) the anterior eye
involvement was detected: low grade uveitis in 11, moderate uveitis with posterior
synechia formation - in 4; 6 pts. has corneal endothelial cells dysfunction. Two pts.
developed dendritic keratis (infection by HSV); 1 - herpetic iridocyclitis. In 1 case
the typical adenoviral keratoconjunctivitis was detected. 11 pts. with CMV retinitis
received the antiviral treatment (Foscarnet - 5, Cymevene - 6) with good results -
stabilisation of retinitis and desappearance of anterior eye lesions were achived in
6 cases. We used comined antiherpetic treatment - interferon inducer (Poludan)
in instillations and acyclovir 3% oinment in pts. with herpetic deseases; in all 3
cases remission was achived and no visual disturbances presented. Adenoviral
keratokonjunctivitis was succesfully treated by Poludan eyedrops only.
Conclusions: Malfunction of cell immunity in AIDS pts. predisposed them to
viral lesions of all sheates of the eye. All patients with active untreated CMVretinitis developed complications in the anterior eye segment-uveitis and corneal
endotheliitis. The management of retinitis by antiviral drugs usually arrested them.
Adenoviral and herpetic (HSV) infections of eye were not rare findings. The most
potent method of viral infections management - use of interferon inducers and
chemoterapy - approved his effectivity in AIDS pts. too.
| 32246 Varicella zoster virus associated with rapidly progressive
outer retinal necrosis (PORN)
Diego M. Caiafa1, Adriana G.A. Gamba2, Leonardo D.L. D'Alessandra2,
Alejandro L.A. Lepetic2, Isabel C.I. Cassetti2. 1Peru 1515; 2Helios Salud,
Buenos Aires, Argentina

In AIDS patients there are increasing reports of retinal disorders not related to
CMV infection. One of the most frequent etiologic agents is varicella zoster virus
(VZV). We report two cases of progressive outer retinal necrosis (PORN), a
clinical presentation of VZV infection in AIDS patients.
Case 1. A 25-years-old male with AIDS, CD4 count = 22 cells/mm3, presented
with progressive right eye visual deterioration of 1 month evolution. Funduscopic examination showed extensive whitening consistent with retinal necrosis.

No hemorrhagic lesions or vitreous inflammation were observed. The fellow eye
was mildly affected. After anterior-chamber paracentesis, intravenous acyclovir
treatment (10 mg/kg tid) was started. The PCR assay of the aqueous humor was
positive for DNA-VZV. Right eye vision was completely lost.
Case 2. A 38-years-old male with AIDS and CD4 count = 30 cells/mm3 came
to a routine eye examination. Multifocal and peripheral lesions in right eye were
found. They became confluent, causing rapidly progressive loss of vision, which
subsequently involved the fellow eye. A PCR assay for VZV-DNA in the aqueous humor was positive. Acyclovir IV treatment was started without successful
response. At that moment he developed encephalitis, with white matter lesions.
A PCR of the CSF was positive for VZV. Therapy was switched to foscarnet. Retinitis and encephalitis improved markedly, but retinal detachment of the left eye
occurred and surgery was done. Retinitis relapsed during maintenance therapy,
requiring re-induction therapy.
PORN has been only reported in AIDS patients with very low CD4 counts and is
caused by VZV. It is characterized by outer retinal necrosis, peripherally located,
confluent, with centripetal progression. Macula and optic nerve involvement are
early seen. Blindness occurs in 70% of cases. Diagnosis is made by the clinical
presentation and PCR assays in aqueous or vitreous humors. The treatment has
limited effectiveness.
PORN is part of the spectrum of acute retinal necrosis (ARN) in AIDS patients
with severe immunocompromise. Lack of ocular pain and vitreous inflammation
and the early macular compromise are differential characteristics. Both of our
patients showed clinically typical presentation and evolution. PCR has proven
efficacy in establishing the diagnosis; better therapeutical alternatives are still
needed. Some specialists recommend maintenance therapy because of the high
rate of relapse.
32247 Thalidomide as a treatment of HIV-related oral ulcers:
A double-blind placebo controlled clinical trial
Velia Ramirez-Amador1, L. Esquivel-Pedraza2, Se Ponce-De-Leon3,
Sa Ponce-De-Leon3, M. Gonzalez-Guevara2, E. De-La-Rosa-Garcia2,
J. Sierra-Madero3. 1Camino Sta. Teresa 277-9 Col. Parque SD El Pedregal
Mexico, D.F. CP14010; 2UAM-XOCH Imilco, Conasida, Mexico City; 31NNSZ,
Mexico City, Mexico
Objective: To evaluate the efficacy of thalidomide in treating oral aphthous
ulcerations in HIV-infected men.
Methods: A double blind, randomized thalidomide-placebo controlled trial was
performed at the Instituto Nacional de la Nutricion "Salvador Zubiran" (INNSZ) in
Mexico City, from July 1993 to November 1997. HIV-infected subjects with clinical
and histological diagnosis of oral recurrent aphthous ulcerations were enrolled
in the study. Patients received an initial oral dose of 400 mg/d of thalidomide or
placebo for one week, and 200 mg/d for seven weeks. Patients were evaluated
for oral and systemic conditions every week. Fisher's exact test and Wilcoxon's
two-sample ranksum test were used for statistical analysis.
Results: Sixteen homo and bisexual male patients were included in the study.
At baseline the mean age was 32 years old (range 20-46) with a median CD4+
count of 56 (range 3-415). Patients presented a median of 3.5 ulcers (range
1-22), with a median of total ulcer diameter of 3.2 cm. (range 0.8-8 cm), and a
median of 1.5 cm (range 0.3-3 cm) for the largest ulcer diameter. Most ulcers
were located on soft palate, oropharynx, and lip mucosa. Ten subjects were
assigned to receive thalidomide and six placebo. No significant differences of
CD4+ counts, opportunistic infections, weight or CDC-stage of the disease were
observed at baseline between the groups. In the thalidomide group, 9/10 (90%)
patients had complete healing of their ulcers compared with 2/6 (33.3%) of the
placebo group (P = 0.036) at the end of the study. Patients in the placebo group
showed a relapsing course of oral lesions. The thalidomide group developed rash
more frequently than the placebo (P = 0.035). Other side effects were somnolence, weakness and dizziness, which dissappeared after drug suspension. In
eight patients the assigned treatment was interrupted prematurely; four of them
received thalidomide.
Conclusions: Oral aphthous ulcers responded significantly to thalidomide in
HIV infected patients. Although side effects are frequent, they are transient.
Appropriate dose and treatment duration remain to be determined.
32248 | The efficacy and safety of nevirapine (NVP) in clinical
practice: Experience in over 500 patients in the UK
Martin Fisher1 2, A.L. Pozniak3, D.R. Churchill4, I.G. Williams5, P. Hay6,
S. Barton7. 1Royal Sussex County Hospital Brighton; 2Brighton Healthcare
Brighton; 3Kings College Hospital London; 4St Mary's Hospital London;
5University College London Hospitals London; 6St George's Hospital London:
7Chelsea and Westminster Hospital London, UK
Objectives: To determine the virologic activity and safety of NVP administered
via the expanded access programme (EAP) in 6 major treatment centres in the
UK.
Methods: Retrospective and prospective case-note review of patients enrolled

in the NVP EAP at 6 centres prior to December 1997. Demographic details,
prior antiretroviral (ARV) experience, baseline CD4 count and viral load (VL) at
the time of NVP initiation, concomitant changes in ARV therapy, toxicity, and all
subsequent CD4 counts, VLs, and modifications to ARV's were collected.
Results: 579 patients were enrolled by 12/97 at the 6 sites. Of 310 analysed by
1/97, 105 were ARV naive; 47 ARV experienced <3/12s; 158 ARV experienced
>3/12s. Overall baseline median VL was 4.69 log (range 2.62-6.43), CD4 200