Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
This trial is active, not recruiting.
|Sponsor||AJI Pharma USA|
|Trial identifier||NCT00002099, 126B, 92-11-9|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Male or female participants from 18 years up to 60 years old.
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.
|Official title||Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients|
|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.|
Call for more information