Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) compared with ddI alone. To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, T-cell subsets, and a decrease in p24 antigen.
Patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in combination with ddI for at least 26 weeks; those tolerating their dose may be offered continuation of therapy for an additional 26 weeks.
Inclusion Criteria Patients must have: HIV seropositivity. Absolute CD4 count of 200 - 500 cells/mm3. No active opportunistic infection or Kaposi's sarcoma. Prior Medication: Allowed: Prior ddI for no longer than 3 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Lymphoid malignancy. Pancreatitis. Peripheral neuropathy. Critical illness. Concurrent Medication: Excluded: Antiretroviral agents other than ddI. Steroids. Cytotoxic agents. Immunosuppressive agents. Immunomodulators. 1-Thyroxine. Concurrent Treatment: Excluded: Radiotherapy. Prior Medication: Excluded within 1 month prior to study entry: Antiretroviral agents other than ddI (patients may have received prior ddI for no longer than 3 months total). Steroids. Cytotoxic agents. Immunosuppressive agents. Immunomodulators. Prior Treatment: Excluded: Radiotherapy within 1 month prior to study entry. Active drug abuse.