Neuroimmunotherapy with low-dose subcutaneous interleukin-2 plus melatonin in AIDS patients with CD4 cell number below 200/mm3: 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/mm3. The study included 11 patients. IL-2 was given subcutaneously at 3 million IU/ day in the evening 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 greater than 30% occurred in 4/11 (36%) patients, and CD4 cell mean values observed during the study were significantly higher with respect to those found before. In addition, the treatment induced a significant increase in mean number of lymphocytes, eosinophils, T lymphocytes, NK cells, CD25- and DR-positive lymphocytes. Finally, CD4/CD8 mean ratio significantly increased during the study. This preliminary clinical study suggests that the combined neuroimmunotherapy with low-dose subcutaneous IL-2 and MLT may improve the immune status also in AIDS patients with CD4 cell counts below 200/mm3, who generally do not respond to IL-2 alone.
Lissoni
P
P
Divison of Oncological Radiotherapy, San Gerardo Hospital, Monza, Milano, Italy.
Vigorè
L
L
Rescaldani
R
R
Rovelli
F
F
Brivio
F
F
Giani
L
L
Barni
S
S
Tancini
G
G
Ardizzoia
A
A
Viganò
M G
MG
D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy* / Q000276:immunology*; D000328:Adult; D015704:CD4 Antigens / Q000032:analysis / Q000096:biosynthesis; D005260:Female; D016655:HIV Core Protein p24 / Q000097:blood; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D008875:Middle Aged; D015213:Neuroimmunomodulation / Q000187:drug effects* / Q000276:immunology; D019966:Substance-Related Disorders
D015704:CD4 Antigens; D016655:HIV Core Protein p24; D007376:Interleukin-2; D008550:Melatonin