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

Track B: Clinical Science

Tu.B.2329 -Tu.B.2333

Methods: Four hundred mg of ciprofloxacin in a volume of 200 ml wer e adeitnetered over
30 min every I 2 hours to a cohort of AIDS patients. Blood samples v ere obtained after
the first dose and at the steady-state and were assayed for ciprofloxarin by a validated
HPLC method. Pharmacokinetic parameters were calculated by usir'y stands d non compartmental methods.
Results: Seven (5 males, 2 females) AIDS patients aging 30.3 ~ 5.0,,:, e r.eic enrolled. All
of them presented a,,tcc e,, a.tc, febrile illam ness: fever of unkrown 0rigin (3 cases),
lower respiratory trart infcrion,3 cases)
sid and sepsis (I case) S a.u.r. was the infective agent in 2 cases and P r, rynosO, S.
pneumoniue and g -,,p [ S oarioneilo in one
*,., 2 4 a t12 case each.The mean
eas serum concentration/time profile after the
first dose and at trhe ste,,dy-state did not
significantly vary [figur e].t he area under the
concentration/time curve was 12.7 ~ 1.4 mg*h/I wth a mean peak, concentration of 6.4 ~
I.4 mg/I and an elimination half life of 3.6 ~ 1.2 hours.The mean volume of distribution at
the steady-state (Vss) was 136.5 liters.
Conclusions: The pharmacokinetic behaviour of intravenous ciproflexacin oes not seem to
be influenced by disease state in AIDS patients presenting an acute febrie complication.
Our results are consistent with pharmacokinetic data obtained in healthy volunteers.
Fredy Suter, Divisione Di Malattie Infettive, Ospedale, Pizzale Solaro 3, 21052, Busto Ar,
51210, ItalyTel 331-699270 Fax [phone]
Tu.B.2329
PROGNOSTIC FACTORS IN HIV DISEASE:THE BUENOS AIRES COHORT STUDY.
Ben Graciela, Cahn P Santarelli M., Rolon M, Oshiro, G - Perez. H - I-spitai
Fernandez,Buenos Aires Argentina.
Objective: To study progression to AIDS in a seroprevalent cohort
Methods: We studied 328 HIV + patients, on a 6 - months (mo) ba is schedule. Median
time of follow-up was 4 I1.5 months (7- I 20). Survival distributions were estimated by
Kaplan-Meiers method, and differences in time distributions were evaluated log-rank
test.The latter test and the Cox proportional hazard model, were used to asess the effect
of prognostic factors. Patients were staged using WHO Staging System.
Results: Population at baseline: 256 male, 72 female, mean age 27 (15 -63),. 158 homosexuals (HS), 126 IVDA, 44 heterosexuals (HS).Median CD4 count at entry' wvas 624 (68-918).
Stage 1:2 I 2, St 2:25, St 3:65, St 4:26. At 30/I 1/95 35 pts remained rn Stage 1, St 2: 30, St 3:
99, St 4: 164 pts. Median time to AIDS was 54 nmo. At 60 mo esti ated frIee of AIDS survival was 58, 5I and 4 I% for pts in WHO Stages I, 2 and 3. Mediae time to AIDS was 42
mo for homosexuals (HS) and 78 mo for IVDA, not reached for HTSs: for pts aged <27: 9 I
mo, and those >27: 44 mo; males 44 mo, females not reached. AIDS correlated with mortality: having one AIDS-defining disease (ADD) increased risk of death: ()dd s ratio (OR)
13.6 compared with asymptomatic pts; having 2 or more ADD increased the risk 3.46 (OR)
compared with only one ADD. Median time to AIDS was 62 months for Stages I & 2 at
entry and 42 mo. for Stage 3 (p< 0.0010). By Cox multiregressiorn analysis age >27 and
WHO Stage 4 remained as the worst prognostic conditions.
Conclusions: In our seroprevalent cohort median time to AIDS wvi 54 rnonths. WHO
stage 3,age > 27, homosexual behavior, gender, and more than one ADD were identified as
prognostic variables in the univariate analysis. Age and stage remained as unfavorable conditions under Cox multiregression analysis.
Graciela Ben, Grascon 79 (I 18 I) Buenos Aires, Argentina.Tel.: (54 I) 98 I - i 82.8
Fax: (54 I) 983-7774
Tu.B.2330
SIGNIFICANCE OF AN INCREASE IN CD8 + PERIPHERAL BLOOD LYMPHOCYTES
IN RESPECT OF CLINICAL ASPECTS AND DISEASE PROGRESSION DURING HIV
INFECTION.
Bentata-Pessayre M., Attia M., Campos J., Mercadier A., Mosnier A., Berlureau P., Jarrousse B.
SIDA UNITS - Hbpital Avicenne, Bobigny France
Objective: To compare CD4 + cells depletion, clinical parameters a nI disease progression
in patients with and without increase in CD8 + cells.To define the ir imunologic patterns of
these CD8 + cells.
Methods: Multiparametric flowcytometric analysis together with,isolute cell counting in
peripheral blood was performed in a monocentric cohort.All results,re expressed inr mean
+ sem. Comparisons between patients with and without increase in CD8 + cells were
made by chi-square, unpaired t test and simple regression analysis. A p value < 0.05 was
considered significant.
Results: I 13/453 patients (25 %) had CD8 + cells more than 1000/pl 1164: 41. No correlation was found with age, sex, gammaglobulins, CD4 + nor with C I) 19 -, CDS--CD 19 +,
CD3-DR + or CD8-CD38 + absolute cell count. But CD8 + cells count ias strongly related (p - 0.0001) with absolute lymphocytosis (2304 ~ 62) and petrerrage of CD4 + (16,3
~ 0,8),CDI9 + (5,7 ~ 0,4),CD5-CD19 + (0,7 ~ 0,13) and CD8 Ct38 + (23,5 ~ 2,3)
cells but not with CD3-DR + (9,9 + 0,8) cells.
In the whole cohort, lymphocytes were 1523/pl ~ 138 and CD4 234 + a I /pL. 99 (22 %)
patients had AIDS. Increase in CD8 + lymphocytes were significantly noiar" hequent in
Europeans and Africans than in Maghrebins (32 and 33 % vs I 5 %, p 1 110 1) and in
homo-bisexuals than in IVDU and heterosexuals (43 vs 20 and 23 % p 0.0001). CD4 +
cells were higher in the I 13 patients (445/pl ~ 26 vs 274 15. p 0.000 I However during a follow up of 74 months ~ I no difference was found in decrease of CD4 (60/2 ~ 8).
number of deaths (49/453, I 1%) or AIDS defining events (172/453, 38 ).
Conclusion: Increase in CD8 + T cells was observed in 25 % of our pat.ents and is associated with higher CD4 + cells count and increase in activatedT cells. However clinical progression was not different. So, high CD8 cells count seems to be an eaher event in the
course of the disease. Standard multiparametric flowcytometric analysis does nct seem an
accurate clinical pronostic marker
M. Bentata-Pessayre, H6pital Avicenne, 125 route de Stalingrad 9-003 tBobigrny Ceidex
France Thlephone: 48 95 5 I 44 Fax: [phone]

Tu.B.233 I
THE INFLUENCE OF AGE ON HIV DISEASE PROGRESSION VARIES ACCORDING TO
CLINICAL STAGES.
Belanger F*, Meyer L*, Carrd N*, Deveau C*.
SEROCO Study Group*. (* INSERM U292)
Objective: To assess the influence of age at infection on the progression of HIV infection
according to different clinical stages of the disease among non haemophiliac HIV-infected
adults.
Methods: Among patients included in a prospective cohort study (SEROCO), 393 had a
known date of infection and were included a few months after the first HIV+ serology.
Following the 1993 classification of the Centers for, ossoo B.... Disease Control, we estimated risk ratios of disease..". --_... progression for each ten years increase (RR/decade),
- using a Cox model. Global progression (-*C: since
"------ contamination to clinical AIDS), first stage progression
(-B: since contamination to B category) and second
6, r Progression 8 ->C........>c stage progression (B--*C: since B to C: category). ' were studied, fitting models with age as a continuous
I...... variable and adjusting for sexual orientation (SO) and.....,.- existence of symptomatic primary infection (SPI).
Results: During follow-up, II 6 B category and 35 C
category events occurred. Influence of age was important on progression --*C (RR/decade
= 1.9 cC95% [I.3 g2.6]) and on progression B--C (RR/decade = 2.0 ~ IC95% =[I.4;
2.8]) but influence on progression -4B was weaker (RR/decade = I. I; IC95% = [0.9 I.4])
(See Kaplan Meier disease free survival curves and Log rank test).
Conclusion: Influence of age on HIV disease progression seems weaker during initial progression (-B) than in the second stage (B--C). Such differential analysis should improve
the statistical power of studies designed to identify other risk factors.
F. Belanger, INSERM U292, 82 rue du Gendral Leclerc, 94276 Le Kremlin Bicetre Cedex,
France
Tel: [phone] I Fax: 331 45 2 I 2075 email: [email protected]
Tu.B.2332
IMPACT OF PLASMA HIV-I RNA ASSAYS ON THE INITIATION OF ANTIRETROVIRAL
THERAPY IN ASYMPTOMATIC HIV-I INFECTED INDIVIDUALS
Izopet J I, Massie P 2, Pasquier C 1, Marchou B 2, Sandres K I, Cazabat M I, Sayada C 3
Pul acqueline I Laboratoire deVirologie CHUToulouse, 2 Service de Maladies
Infectieuses CHU Toulouse, 3 Roche Diagnostic Systems, Neuilly-sur-Seine, France.
Objective: This study compares the plasma HIV- I RNA concentrations of untreated asymptomatic individuals with CD4 cell counts of >200 cells/mm3 that are above and below the
<<350>> threshold.
Methods: I I 2 consecutive untreated asymptomatic HIV- I infected individuals with CD4 cell
counts of > 200/mm3 were enrolled in a prospective study beginning in May 1995. At
entry, the CD4 cell count was measured and the plasma HIV- I RNA level was measured
using the AmplicorTM HIV-I MonitorTM assay (Roche).The short-term biological variability
was assessed by measuring HIV- I RNA again 6 weeks later in 35 patients.
Results: I/ Overall, 1I 10 of 1I 12 (98.2 %) patients had quantifiable HIV- I RNA (2.3 - 5.58 log
copies/ml). 2/The biological variabilities in these clinically stable individuals was 0.22 log. 3/
HIV- I RNA levels (mean ~ sd log-copies) were 4.47 ~ 0.61, 4.21 ~ 0.74 and 3.87 ~ 0.78 in
patients with CD4 cell counts of 200-349, 350-499 and > 500/mm3, respectively (p <
0.005). I19% of the patients with CD4 cell counts > 500m/mm3 and 4 I % of those in the
350-499 stratum had values above 4.5 log-copies/ml:
HIV- I RNA 200-349/mm3 350-499/mm3 500/mm3
(log copies/ml) (n = 27) (n = 27) (n =58)
mean ~ standard deviation 4.47 ~ 0.61 4.21 + 0.74 3.67 ~ 0.78
< 3.5 3 (11.1 %) 6(22.2%) 21 (36.2%)
3.5 4.5 12 (44.4 %) 10 (37.0 %) 26(44.8%)
4.0-5.0 12(44.4%) II (40.8 %) II (19.0%)
Conclusions: I/This study demonstrates the virologic heterogeneity, as reflected by plasma
HIV- I RNA, in asymptomatic patients, whatever the CD4 cell stratum. 2/In view of the
development of multi-drug combinations, the concept of an early combination anti-retroviral therapy in asymptomatic patients with CD4 cell counts of > 350/mm3 tailored to subjects with more than 4.5 log copies/ml should be considered. 3/ Because HIV-I RNA concentration can anticipate the fall in the CD4 cell count, the availability of sensitive standardized assays for quantifying HIV- I RNA could have a major impact on decisions to initiate
treatment in clinical practice.
Jacqueline PUEL - Laboratoire de Virologie - CHU Purpan - Place du Docteur Baylac -
31059Toulouse Cedex - France -Tel: [phone] - Fax: [phone]
Tu.B.2333
IMMUNOGLOBULIN-E (IGE) SERUM LEVEL:A PROGNOSTIC MARKER FOR AIDS IN
HIV-INFECTED ADULTS?
Rancinan C. Chitne G*, Morlat P**, Guez S~, Dequae-Marchadou L*, Beylot J**, Salamon
R*. *INSERM U330, 33076 Bordeaux Cedex, France; ** Hfpital Saint-Andr8, 33075
Bordeaux Cedex, France; ~ Hbpital Pellegrin-Tripode, 33076 Bordeaux Cedex, France.
Objective: To study progression to AIDS or death according to IgE serum level in adults.
Methods: A prospective cohort of HIV-infected adults set up for studying allergic symptoms. IgE serum level (Pharmacia FEIA) was systematically measured in II 5 patients followed in an infectious ward of a University Hospital. Probability of progression to AIDS or
death was estimated using Kaplan-Meier method. A Cox model was used to estimate the
independent effect of IgE on progression to AIDS or death, adjusted for: sex, age, HIV transmission category clinical stage, CD4+ cell count, hemoglobin level, prophylactic treatment of
PCP and antiretroviral therapy
Results: The mean age at inclusion was 36.5 years (range: 22-70).Clinically 42 patients
(36%) were classified in category A, 43 (38%) in category B, 30 (26%) in category C.The

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