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Session 61 Poster Session Antiretroviral Chemotherapy in Previously Treated Individuals Session Time: 4:30-6:30 pm Room 4E-F

424-W. The HYDILE Trial: A Quadruple Combination of Nucleoside Analog ± Hydroxyurea and IL-2 as Salvage Therapy for HIV Infection A. Lafeuillade*, G. Hittinger, S. Chadapaud, and C. Poggi Toulon, France Background: Our objective was to evaluate the efficacy of a RTI regimen, with or without hydroxyurea (HU) and interleukin-2 (IL-2), in HIV-infected patients failing PI-containing regimens. Methods: Randomized study comparing D4t + ddI + abacavir + efavirenz (group 1) to the same regimen + HU at 500 mg BID (group 2), to the same regimen + HU and IL-2 at 4.5 MUI BID for 5 consecutive days, 3 courses (group 3) in patients failing PI-containing regimens but naïve of NNRTI and abacavir. Efficacy was assessed by intent-to-treat (ITT) (missing = failure) and on-treatment (OT) analysis. Results: 69 patients have been included (group 1: 23, group 2: 23, group 3: 23). The median number of previously received drugs was 4 for RTIs and 2 for Pis. Baseline mean CD4 was 386 cells/µL, mean viral load (VL) was 4.01 log (median: 3.92); 71% of patients had * 3 ZDV resistance mutations and 42% had a M184V mutation on plasma sequencing. All patients were ZDV experienced and 87% were d4T experienced. In an ITT analysis at 24 weeks, 33.3% (group 1), 76.1% (group 2), and 58.8% (group 3) had VL <200 copies/mL (p = 0.01), while in an OT analysis 47.0% (group 1) vs 81.2% (group 2+3) had VL <200 copies/mL (p = 0.01). In an ITT analysis at week 48, 20.8% (group 1), 52.3% (group 2), and 41.1% (group 3) had VL <200 copies/mL (p = 0.04), while in an OT analysis 50.0% (group 1) vs. 62.1% (group 2+3) had VL <200 copies/mL (p = 0.09). In an ITT analysis at week 48, 16.6% (group 1) and 42.1% (group 2+3) had VL <50 copies/mL (p = 0.03), while in an OT analysis 40% (group 1), 58.8% (group 2), and 50% (group 3) had VL <50 copies/mL (p = 0.07). At week 48, a mean gain of 104 CD4 was observed in group 1, a mean decrease of 29 in group 2 and a mean gain of 77 in group 3. The final analysis of the trial is scheduled during December 2001. Conclusions: These preliminary results suggest that such a quadruple regimen keeps activity in multiply RTI experienced patients and is enhanced by the addition of HU. Although the use of IL-2 did not modify the antiviral response, it was able to attenuate the cytotoxic effects of HU.

©2002 9th Conference on Retroviruses and Opportunistic Infections