Preliminary Data--HAART + Immune Based Therapies (Remune, IL-2)

Italian investigators Rizzardi and Pantaleo reported preliminary data at ICAAC on an ongoing study (n=34) comparing HAART to HAART+IL-2 and HAART+Remune. Patients receive one of two bid HAART regimens: abacavir 300mg+nelfinavir 1250mg+Fortovase 1200mg bid or abacavir+nelfinavir+amprenavir 1200mg. Subcutaneous IL-2 was given as 8 5-day cycles every 4 weeks and every 6 weeks after 3rd cycle.  Remune was given 10 ug/ml p24 every 3 months. Patients were treatment-na´ve with mean baseline CD4 and viral load of 623 and 53,000 copies/ml. After 48 weeks (n=14), there was a 4 log reduction in viral load when using a sensitive boosted Amplicor test measuring to 5 copies/ml. The reduction was 2 log using the standard Amplicor 400 copy test. Investigators reported there were no virological differences between the three arms as they were all well suppressed: at week 48 (n=18), 70% < 50 copies/ml, 60% <5 copies/ml, ITT. The CD4 increases in the IL-2 arm were significantly more than in other two arms at week 48 (about 750 cells at wk 48). Investigators said patients in Remune arm had significant lymphocyte proliferative responses to HIV antigen at about week 36. About 60% (n=8) in Remune arm at week 33 developed positive HIV-DTH response. The clinical benefit of improved lymphocyte proliferative response to HIV antigen has not yet been established. The study investigators said individuals will be permitted to stop therapy after about 5 more months. It is at that time investigators said we will be able to observe if Remune plays a role in controlling HIV when taken with HAART.