Document 2842 DOCN M94A2842 TI Phase II study of combination of lentinan with ddI in HIV-positive patients. DT 9412 AU Kaneko Y; Mimura T; Guralnik M; Baker M; Goodgame J; DeMarzo C; Pierce D; Lang W; Gordon M; Ajinomoto Co., Inc., Tokyo, Japan. SO Int Conf AIDS. 1994 Aug 7-12;10(1):212 (abstract no. PB0276). Unique Identifier : AIDSLINE ICA10/94369733 AB OBJECTIVE: To assess the safety and efficacy of a combination of ddI (didanosine) and lentinan (an immune modulator) in HIV-positive cases. METHODS: Didanosine was administered to HIV-positive individuals with CD4 levels of 200-500 cells/cmm at a dose of 400 mg/day (po) for six weeks (bid), then 2 mg of lentinan iv was added per week for 24-80 weeks. A control group (20%) received ddI only. About 70 patients have been enrolled to date out of a target of 100 patients. Laboratory parameters measured were CD4, p24 antigen, chemistry, hematology and T-cell panels. RESULTS: The combination was well tolerated and no unexpected side effects were observed. Patients generally had improved CD4 levels and a reduction in p24 antigen, although the study is still blinded. CONCLUSION: Because of the refractory nature of HIV disease it is recommended that the above combination of ddI and lentinan be supplemented with interleukin-2 and/or curdlan sulfate. DE Adjuvants, Immunologic/*THERAPEUTIC USE Combined Modality Therapy Comparative Study Didanosine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Glucans/ADMINISTRATION & DOSAGE/THERAPEUTIC USE Human HIV Infections/DRUG THERAPY/*THERAPY Interleukin-2/ADMINISTRATION & DOSAGE/THERAPEUTIC USE Lentinan/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Safety Treatment Outcome CLINICAL TRIAL CLINICAL TRIAL, PHASE II MEETING ABSTRACT SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).