1. TO EVALUATE EARLY ANTIVIRAL RESPONSE AND SAFETY OF A DUAL BOOSTED PROTEASE INHIBITORS REGIMEN INCLUDING LOPINAVIR/r (LPV) PLUS AMPRENAVIR (AMP) OR FORTOVASE (FTV) IN HEAVILY PRETREATED HIV INFECTED PATIENTS. Zala, C.; Patterson, P.; Coll, P.; Bouzas, M. B.; Kaufman, S.; Gun, A.; Pérez, H.; Cahn, P. Fundación Huésped, Buenos Aires, Argentina. RESULTS: From July 00 to Jan 01, forty two (42) consecutive patients (8 women) received a prescription for LPV+AMP (19) and LPV+FTV (23). Twenty seven (64%) had prior AIDS defining illness. Median plasma HIV RNA at BSL was 358.125 cps/mL (5,55 log10) with no significant differences between the AMP and the FTV pts. Median BSL CD4 T cell count was 93/mm3 (2-383). Prior number (mean) of prescribed PIs was 3 per patient. By June 01, one FTV patient died due to lymphoma. Seven patients (3 AMP and 4 FTV) discontinued therapy due to GI intolerance and/or poor adherence. Twenty five (25) patients have completed 48 weeks follow up. Median plasma HIV RNA decline from baseline was 3,0 log 10. Twenty (20) out of 25 patients (80%) had HIV RNA reductions from BSL greater than 1 log10 (7/10 (70%) AMP, 13/15 (86,7%) FTV). Proportion of patients with pVL <500 cps/mL (ITT, nc=failure) at 48 weeks follow up was 31% (4/19 (21%) AMP, 9/23 (39,1%) FTV). Four patients experienced Grade III/IV increase in cholesterol and/or triglycerides levels. No treatment limiting toxicity was reported. CONCLUSIONES: Within this cohort, a double boosted PI regimen including Lopinavir/r in addiction to either Amprenavir or Fortovase allowed to rescue one third of patients experiencing multiple treatment failure with no significant toxicity. OBJECTIVES: To evaluate efficacy and safety of a dual boosted PI regimen including Lopinavir/r (LPV) plus Amprenavir (AMP) or Fortovase (FTV) in heavily pretreated HIV infected patients. METHODS: Prospective, open label, observational cohort study of patients referred to a single HIV clinic for prescription of a salvage regimen. Eligible patients for analysis are those who failed 3 drug classes and consented to receive LPV (3 capsules BID or 4 BID if a concomitant NNRTI was prescribed) plus either AMP or FTV dosaged at 750 and 1000 mg BID respectively. Second PI (AMP or FTV) was prescribed according to patients and physician preferences. Backbone nucleosides and/or NNRTIs were prescribed according to patient drug history. Plasma HIV RNA, CD4 cell count and safety lab were measured at regular intervals. Tolerability and compliance were evaluated on monthly basis. PATIENTS CHARACTERISTICS AMPFTVTOTAL n 192342 Age (median yrs) 38,736,437,4 Male 13/19 (68%)21/23 (91%)34/42 (81%) Prior AIDS 14/19 (74%)13/23 (57%)27/42 (64%) NADIR CD4 cell count (median) 27/mm340/mm339,5/mm3 BSL CD4 Cell count (median) 90/mm396/mm393/mm3 BSL pVL (median) 307.000 (5,49)402.000 (5,60)358.125 (5,55) Corresponding author: Carlos Zala, MD. czala@huesped.org.ar AMPFTVTOTAL Prior exposure to PI’s (mean) 3,3 (1 – 5) 3,0 (1 - 4) 3,2 (1 - 5) Prior exposure to NRTI’s (mean) 5,0 (4 – 6) 4,5 (3 – 6) 4,7 (4 – 6) Prior exposure to NNRTI’s (mean) 1,3 (0 – 3) 1,0 (0 – 2) 1,1 (0 – 2) Prior exposure to hydroxiurea (mean) 9/19 (47%)6/23 (26%)15/42 (36%) Pts. off therapy at BSL 9/19 (47%)15/23 (65%)24/42 (57%) THERAPY DISCONTINUATIONS AMP n=19 FTV n=23 TOTAL n=42 DEATH* ADVERSE EVENT GI INTOLERANCE POOR COMPLIANCE VIROLOGICAL FAILURE 1030510305 2122121221 3152631526 THERAPY D/C9817 Backbone NRTI’sAMPFTVTOTAL ABACAVIR STAVUDINE LAMIVUDINE DIDANOSINE ZIDOVUDINE 10 8 2 4 0 14 7 2 0 24 15 4 0 Backbone NNRTI’s EFAVIRENZ NEVIRAPINE 5050 7171 12 1 PATIENTS DISPOSITION AMPFTVTOTAL SCR192342 BSL182240 W 4-8162036 W 12151732 W 2413162929 W 36121628 W 48*101525 13001300 FASTING TRIGLYCERIDES Normal Range: 0,7 - 1,7 mmol/L FASTING CHOLESTEROL Normal Range: 3,9 – 5,2 mmol/L HIV RNA CHANGE AT WEEK 48 (ITT) PROPORTION OF PATIENTS WITH HIV RNA <500 cps/mL (ITT) *2 deaths before BSL *17 patients d/c therapy n12 - 4 - 817 - 7 - 1016 - 6 - 1014 – 4 - 1013 – 4 - 9n513161920 n40 - 18 – 22 BSL 35 - 16 – 19 WEEK 4-8 32 - 15 – 17 WEEK 12 29 – 13 – 16 WEEK 24 28 – 12 – 16 WEEK 36 25 – 10 – 15 WEEK 48 n40 - 18 – 22 BSL 35 - 16 – 19 WEEK 4-8 32 - 15 – 17 WEEK 12 29 – 13 – 16 WEEK 24 28 – 12 – 16 WEEK 36 25 – 10 – 15 WEEK 48