HIV Infections Clinical Trial
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
NCT number | NCT00002099 |
Other study ID # | 126B |
Secondary ID | 92-11-9 |
Status | Active, not recruiting |
Phase | Phase 2 |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
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.
Status | Active, not recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | HIV Research Group | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
AJI Pharma USA |
United States,