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ILSTIM (ANRS 082)-A Randomized Comparative Open-Label Study of Interleukin w(IL2) in Patients with CD4 <200/mm3 Despite Effective HAART C. KATLAMA*1, C. DUVIVIER1, C. CHOUQUET2, B. AUTRAN1, G. CARCELAIN1, M. DE SA1, L. ZAGURY1, D. COTAGLIOLA2, and R. TUBIANA1.
1Hopital Pitie-Salpetriere; 2SC4 INSERM Paris, France
Objective: To evaluate immunological efficacy, tolerance and safety
of scIL2 in patients with persistent low CD4 cells (<200/mm3)
despite efficient HAART.
Patients and methods: 72 patients with CD4<200/mm3,
HIV RNA < 1000 copies/ml under > 6 months HAART were randomized to receive
sc IL2 4.5 MIU bid in 4 cycles of 5 days every 6 weeks (W) up to W24 in
addition to their prior HAART (IL2 group) or to maintain HAART alone (control
group). After 24 weeks, IL2 was given as sc IL2 9MIU QD x 5 days every
8 weeks to patients from both groups up to W80. Biological, immunological,
virological parameters were evaluated at each cycle.
Results: 70 patients were evaluated over 24 weeks; 3 patients discontinued
study treatment. Preliminary results by intent to treat analysis at W24
are shown below
No unexpected adverse effect was observed; IL2 was discontinued in 1 pt
and dose reduced in 5 pts; 8 pts (7 vs 1) pts had transient increase in
VL > 1000 cp/ml; at W24, 4 pts had VL between 1000 and 3000 cp/ml. Improvement
in CD4 cells phenotypes, specific CD4 and CD8 response to recall antigens
and to HIV antigens will be presented.
Conclusions: IL2 increases significantly the number of CD4 cells
(+ 65/mm3; p< 10-6<$>) over 24 weeks in patients with persistent
low CD4 lymphocytes despite HAART. Tolerance was quite acceptable; longer
follow-up will be presented.
Key Words: HAART, interleukin 2, late stage disease
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