10th Conference on Retroviruses and Opportunistic Infections Boston, MA USA - February 10 -14, 2003

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 62
Y Levy¹ , H Gahery-Segard², C Durier³, A-S Lascaux¹, V Meiffrédy³, C Goujard⁴, J-P Cassuto⁵, C Rouzioux⁶, R Elhabib⁷, J-G Guillet⁸, J-P Aboulker³, J-F Delfraissy⁴, ANRS 093 Study Group^9
1Hosp Henri Mondor, Créteil; ²INSERM, U445, Paris; ³INSERM, SC10, Villejuif; ⁴Hosp Bicêtre, Kremlin-Bicêtre, France; ⁵Hosp Archet, Nice, France; ⁶Hosp Necker, Paris, France; ⁷Aventis Pasteur, Lyon, France; ⁸Hosp Cochin, Paris, France; and ⁹Agence Natl de Res sur le SIDA, Paris, France Paris, France

BACKGROUND: To evaluate the immunogenicity of the vaccine strategy and its impact on HIV replication after HAART discontinuation.

METHODS: Seventy (70) patients (pts) with CD4 > 350 cells/ml and HIV RNA < 50 cp/ml, treated for at least 1 yr with HAART alone (n = 55) or combined with IL-2 (n = 15), were randomized to continue either HAART alone (control, n = 37) or combined with ALVAC and Lipo-6T administered at wk 0, 4, 8 and 12 followed by 3 cycles of IL-2 (4.5 MIU, bid, 5 d) at wk 16, 24, 32 (Vac-IL-2, n = 33). Pts whose plasma HIV RNA was < 50 cp/ml at wk 36 were proposed to stop HAART at wk 40. Intent-to-treat analysis of: 1) proportion of pts with virological failure at wk 52 defined by re-initiation of HAART if viral load > 50,000 at wk 44 or after wk 48 if > 10,000 cp/ml; 2) LPR to p24 and 11 peptides from gag, pol, nef, and env, was done.

RESULTS: At wk 40, 63/69 (91%) pts stopped HAART. At wk 52, 2/37 (5%) controls and 8/33 (24%) vaccinated were off HAART (p = 0.027). Time (median, d) to peak of HIV RNA and to virological failure was delayed in Vac-IL-2 arm (41.5 and 42) compared to controls (34 and 29) (p = 0.02 and 0.009, respectively). Prior IL-2 therapy (trend, p = 0.13) and lower proviral DNA at wk 0 (p < 0.001) were associated with HIV control at wk 52, but the comparison between vaccinated pts and controls remains significant after adjustment on these baseline factors (p = 0.032). In Vac-IL-2 arm, number of pts with a sustained p24 LPR at wks 16 and 36 (15/32) and with LPR = 1 peptide (19/33) was significantly higher than controls (8/33 and 9/36) (p = 0.049 and 0.006, respectively). Logistic-regression analysis demonstrated that these 2 parameters were predictive of HIV control at wk 52 (p = 0.046 and 0.014).

CONCLUSIONS: Vaccinated pts experienced a better control of HIV replication after stopping HAART. This effect is associated to the stimulation of a sustained and a polyepitopic HIV immune response.

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