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

12th World AIDS Conference

Abstracts 12397-12401 93

dose. Physicians were asked to complete and return the action form within 24
hours of receipt.
Results: This process has been successful in optimizing indinavir dosing in
combination with nevirapine in 86.5% (96/111) of patients initially prescribed
indinavir at a dose outside of suggested dosing guidelines.
A nationwide prescriber-targeted educational process is effective in optimizing
indinavir therapy in combination with nevirapine.
S12397 Peripheral neuropathy during stavudine-didanosine
combination therapy (QUINTET Trial)
Francois Raffi1, Jean Marie Mussini2, V. Reliquet2, J.M. Chennebault1, A. La
Feuillade2. 1Maladies Infectieuses Hotel-Dieu, 44035 Nantes Cedex; 2Cisih
Hotel-Dieu, Nantes, France
Objective:To assess incidence, evolution and predictive factors of peripheral
neuropathy occurring during stavudine-didanosine combination therapy.
Methods: Sixty-five HIV-infected patients (pts) with prior antiretroviral therapy
>3 months, and naive for ddl and d4T, were included in QUINTET trial (ICAAC
1997). They received ddl (200 mg BID, 125 mg BID if <60 kg) + d4T (40 mg
BID, 30 mg BID if <60 kg) for 24 weeks with extension for 24 more weeks in
case of RNA response below 500 copies/ml. Addition of 3600 mg/day saquinavir
was permitted in pts with insufficient antiviral response at week 24. Among the 65
pts, 23 had a neurological evaluation either systematically (n = 17) or for adverse
neurological events (n = 6): clinical examination and standardized electromyography (EMG) protocol, with measurement of at least 3 different motor and sensory
nerve conduction velocity (SNCV), and 3 muscle needle EMG.
Results: Seven of the 65 pts (10.8%) exhibited mild sensory peripheral neuropathy (PN) with mild paresthesia, loss of achillean reflexes and distal thermic or
pink-prick sensation. Axonal sensory neuropathy could be detected by mean of
SNCV in 7/7 pts. PN occurred between week 11 and 47 (mean: 23) of stavudinedidanosine treatment and led to interruption of stavudine in only one patient before
week 24; in the others, reducing stavudine dosage led to symptoms improvement.
None of baseline parameters was predictive of PN: previous nucleoside treatment
with zidovudine (n = 65) and/or zalcitabine (n = 28), mean CD4 cell counts (PN
= 189/mm3 vs no PN = 232/mm3), mean plasma HIV RNA (PN = 5.1 loglo vs no
PN = 4.9 loglo), previous neurological abnormalities (PN = 2/7 vs no PN = 4/58),
stavudine daily dose (PN = 1.24 mg/kg/d vs no PN = 1.12 mg/kg/d).
Conclusion: Benign sensory reversible peripheral neuropathy could hazardously be encountered in 10.8% patients treated for one year with stavudinedidanosine combination. No predictive factors of peripheral neuropathy occurrence could be identified.
112398 Expanding the spectrum of protease inhibitors-induced
lipodistrophy
Vicente Boix, S. Reus, M. Priego, E. Merino, F. Roman, E. Climent, J. Portilla.
Capitan Lagier 6, Hospital General Universitario Alicante, Alicante, Spain
Background: In the last months, protese inhibitors-induced lipodistrophy (PIIL)
is emerging as a growing problem. The clinical spectrum and the array of the
offending drugs seem to be expanding.
Objectives: To describe the incidence, clinical findings, timing and follow up of
PIlL in a University Hospital.
Design and Methods: We made a revision of the 272 clinical charts of patients
receiving protease inhibitors (PI) in our outpatient clinical looking for changes in
body fat and we designed a especial questionary about PIIL that was performed
to every patient taking PI.
Results: We detected 5 cases (prevalence of PIIL in patients taking IP 1.8%).
3 males, 2 females. Mean age 38 years (29-47). Fat changes began between
months 2 and 6 of treatment. 3 patients were receiving indinavir, 1 saquinavir
and in 1 case fat changes began during treatment with saquinavir and worsened
after switching to ritonavir. Fat accumulated in the abdomen in 3 cases, mainly in
epigastrum, breasts in 3 cases (2 females) and face, neck, shoulders and upper
thorax mimicking a Gushing or a superior cava syndrome in 1 patient. 4 patients
reported slimming affecting: face (3), arms (2) or legs (2). None developed significant changes in body weight. Although ongoing treatment with IP, fat changes
stopped in 3 patients between 2 and 12 months after being noticed. One patient
has mild abdominal changes and continues with the IP. IP had to be stopped because of progressive, deforming fat changes in one patient, one woman needed
psychologic care after her breasts enlarged to three times the previous size. No
patient had pain, reddeness or nodes in the affected areas. The virologic and
immunologic responses to IP containing triple therapy were normal. Prevalence
of PIIlL in patients receiving IP: indinavir 3/157, saquinavir 2/70, ritonavir 1/45
Conclusion: 1. PIIlL is a relatively common finding that can appear in patients
with indinavir, saquinavir or ritonavir. 2. PIIL is usually a self-limited problem and
treatment needs not to be stopped. 3. Sometimes, progressive deformation or
psychological problems can appear and the IP has to be stopped.

12399 Indinavir-related nephrolithiasis is associated with
environmental temperature
E. Martinez, M. Leguizamon, A. del Rio, A. Rodriguez, J.M. Gatell. Hospital
Clinic, Barcelona, Spain
Background: Nephrolithiasis is the main adverse effect associated with indinavir
use. The reported incidence by the manufacturer is 5 percent. We have observed

a variable incidence of nephrolithiasis along one-year in the adult HIV-1 infected
population who used indinavir at our hospital.
Objective: To study the potential correlation between the incidence of indinavir-related nephrolithiasis and environmental factors.
Methods: We retrospectively studied the incidence of nephrolitiasis (defined
as flank pain with hematuria) in patients taking indinavir as a part of their antiretroviral regimen from november 1996 until october 1997 (first 12 months of
commercial use of indinavir at our hospital). We calculated the incidence as the
monthly number of episodes of nephrolithiasis per 100 patients exposed. The
National Institute of Meteorology at Barcelona provided us the average values
of temperature, humidity and atmospheric pressure in the city of Barcelona during the study period. We tried to find if there was any correlation between the
incidence of nephrolithiasis and each one of those atmospheric variables.
Results: The incidence of nephrolithiasis ranged from 0 to 10.2 episodes per
100 patients exposed per month. The maximal peak incidence was observed in
the late summer and the early autumn. The monthly incidence of nephrolithiasis
showed a good correlation with temperature (R-squared: 0.76; p = 0.0002), but no
with humidity (R-squared: 0.105; p = 0.3) and atmospheric pressure (R-squared:
0.007; p = 0.8).
Conclusions: The incidence of indinavir-related nephrolithiasis depends on
the environmental temperature. The increased risk may be due to a higher water
loss by sweating. The manufacturer of indinavir recommends to take 1.5-2 litres
a day of water to prevent nephrolithiasis; however, this volume should be higher
during the warm months in those areas of the world with a mediterranean weather.
We greatly appreciate the help of the Instituto Nacional de Meteorologia,
Ministerio de Medio Ambiente.
12400 Factors related to adherence (ADH) with protease
inhibitors
Patrick M. Nemechek1, Maura Conry2, Alex Westerfelt2, Byron Eicher3,
George Wine Chase3. 17301 Mission Road Suite 339, Prairie Village, Kansas
66208; 2University of Kansas School of Social Welfar, Lawrence KS: 3The
Comprehensive Immunology Center, Prairie Village KS, USA
Methods: Three focus groups with approx. 10 men each were conducted in one
medical care setting. Areas explored included their understanding HIV, sources
of information, strategies for staying on schedule, situations which frustrate ADH,
and their advice for monitoring ADH.
Results: Participants ranged in age from 26 to 61 and had been diagnosed
HIV+ 5 years ago on average. Primary findings included a lack of knowledge
about how the virus acts and the way in which missed doses affect the course
of the virus. Primary source of knowledge was the primary care physician; secondary source was pharmaceutical advertising in popular press magazines. No
one utilized a pharmacist for information; filling prescriptions was regarded as
incidental at best, a potential for public disclosure of one's diagnosis at worst.
ADH was most difficult on weekends because of changes in routine, and for midday doses. As the number of meds increased and dosing schedules grew more
complex, ADH was more difficult. Side effects inhibited ADH, and the men stated
that more information about what to expect regarding the duration and severity
of side effects is more helpful. Some indicated they were not always honest with
medical staff regarding side effects, either for fear of being a "complainer" or ARV
discontinuation.
Conclusion: Strategies to facilitate and monitor ADH included developing a
strict routine and trusting relationships with medical care providers. The men also
reported that they would find it easier to record missed doses (always realized
later) than each dose taken.
I12401 | Nelfinavir-associated diarrhea is manageable with
nonprescription medications
Trevor Hawkins. Southwest C.A. R.E. Clinic, 230 West Manhattan Ave. Suite
300, Sata Fe, NM 87501, USA
Background: Diarrhea commonly occurs as a side effect of treatment with the
protease inhibitor nelfinavir (NLF) for HIV infection. Clinicians have recommended
psyllium husk (PH) and other over-the counter remedies to patients for relief of
NLF-associated diarrhea.
Objectives: To determine the prevalence of use of PH among patients with
NLF-associated diarrhea and its effectiveness against the side effect.
Methods: In a telephone survey, interviewers administered a 21-item questionnaire to patients in a HIV disease clinic who had been prescribed NLF.
Results: Of the 77 respondents, 68 (88.3%) were male, with a mean age of
39.4 years. Homosexual activity was reported as the most likely route of infection
by 60 (77.9%); 42 respondents (54.5%) had at least a five-year history of HIV
infection. Of the respondents, 20 (25.9%) reported using PH. The most common
reported dosing frequency was once daily (10). PH users had a mean viral load
of 83,672 copies HIV/RNA/mm3 and a mean CD4 count of 307.8 cells/mm3.
Of the PH users, 11 (55%) said they had less frequent stools, 8 (40%) noted

improvement in stool quality, and 11 said PH had made it easier to adhere to
NLF. Those who reported PH did not help in adherence to NLF had a lower
mean CD4 count than those who said it did (207 cells/mm3 compared with 325
cells/mm3), although mean viral load was lower as well in the former group (30,817
copies HIV/RNA/mm3 versus 105,179 copies HIV/RNA/mm3). Respondents also
commented that diarrhea was relieved by other agents, including loperamide.
Conclusion: Diarrhea associated with nelfinavir treatment often can be managed by the patient with widely available over-the-counter medications.