NEUROIMMUNOTHERAPY WITH LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 PLUS MELATONIN IN AIDS PATIENTS WITH CD4 CELL NUMBER BELOW 200 MM(3) - A BIOLOGICAL PHASE-II STUDY/

A phase-II pilot clinical study was performed to evaluate the effects of low-dose subcutaneous IL-2 with the pineal hormone melatonin (MLT) in AIDS patients with CD4 counts below 200/mm(3). The study included I I patients. IL-2 was given subcutaneously at 3 million IU/day in the e vening for 6 days/week for 3 weeks. MLT was given orally at 40 mg/day in the evening every day, starting 7 days prior to IL-2. The treatment was substantially well tolerated and in particular no cardiovascular or pulmonary complication occurred An increase in CD4 cell number grea ter than 30% occurred in 4/11 (36%) patients, and CD4 cell mean values observed during the study were significantly higher with respect to t hose found before. In addition, the treatment induced a significant in crease in mean number of lymphocytes, eosinophils, T lymphocytes, NK c ells, CD25- and DR-positive lymphocytes. Finally CD4/CD8 mean ratio si gnificantly increased during the study. This preliminary clinical stud y suggests that the combined neuroimmunotherapy with low-dose subcutan eous IL-2 and MLT may improve the immune status also in AIDS patients with CD4 cell counts below 200/mm(3), who generally do not respond to IL-2 alone.