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-naïve 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.