Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Lentinan
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lentinan|nan|
|Drug: Didanosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Lentinan