A phase II controlled study of a combination of the immune modulator, lentinan, with didanosine (ddI) in HIV patients with CD4 cells of 200-500/mm3.
This study was carried out to assess the safety and efficacy of a combination of lentinan, an immune modulator, and didanosine (ddI) in a controlled study in HIV positive patients with CD4 levels of 200-500 cells/mm3. Didanosine was administered to HIV patients at doses of 400 mg/day (po) for six weeks (bid), then 2 mg of lentinan i.v. was added per week for 24-80 weeks. A control group (20%) received ddI only. A total of 107 patients were enrolled at three sites, and 88 patients started the ddI/lentinan phase. The combination caused significant increases in CD4 levels up to 38 weeks, whereas ddI alone was significant at the 5% level at 14 weeks. Based on these data, lentinan qualifies as a participant in future multi-drug studies in HIV.
Gordon
M
M
AJI Pharma USA, Inc., Teaneck NJ 07666, USA.
Guralnik
M
M
Kaneko
Y
Y
Mimura
T
T
Goodgame
J
J
DeMarzo
C
C
Pierce
D
D
Baker
M
M
Lang
W
W
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D015704:CD4 Antigens / Q000032:analysis*; D016049:Didanosine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology; D006801:Humans; D007912:Lentinan / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
D000276:Adjuvants, Immunologic; D015704:CD4 Antigens; D007912:Lentinan; D016049:Didanosine