Expired Study
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San Diego, California 92102


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00002099


Primary Contact:

Study Chair
Pearce D


Backup Contact:

N/A


Location Contact:

San Diego, California 92102
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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