HIV Infections
Conditions
Keywords
Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Lentinan
Brief summary
To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) in comparison 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.
Detailed description
Patients are treated with daily oral ddI for 6 weeks, then are randomized to ddI in combination with intravenous lentinan or placebo (administered once weekly) for 26 weeks. Patients who are already stabilized on 400 mg/day ddI will proceed directly to randomization. Following completion of the combination therapy, patients may be offered 26 additional weeks of therapy on an optional basis.
Interventions
DRUGLentinan
DRUGDidanosine
Sponsors
AJI Pharma USA
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 IV drug abuse.
Countries
United States
Outcome results
None listed