Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
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ClinicalTrials.gov Identifier: NCT00002099
Verified July 1994 by NIH AIDS Clinical Trials Information Service. Recruitment status was: Active, not recruiting
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.
Condition or disease
Drug: LentinanDrug: Didanosine
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.
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Absolute CD4 count of 200 - 500 cells/mm3.
No active opportunistic infection or Kaposi's sarcoma.
Prior ddI for no longer than 3 months.
Patients with the following symptoms or conditions are excluded:
Antiretroviral agents other than ddI.
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).
Radiotherapy within 1 month prior to study entry. Active IV drug abuse.