Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV seropositivity.
- •Absolute CD4 count of 200 - 500 cells/mm
- •No active opportunistic infection or Kaposi's sarcoma.
- •Prior Medication:
- •Prior ddI for no longer than 3 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Lymphoid malignancy.
- •Pancreatitis.
- •Peripheral neuropathy.
- •Critical illness.
- •Concurrent Medication:
- •Antiretroviral agents other than ddI.
- •Steroids.
- •Cytotoxic agents.
- •Immunosuppressive agents.
- •Immunomodulators.
- •1-Thyroxine.
- •Concurrent Treatment:
- •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:
- •Radiotherapy within 1 month prior to study entry. Active IV drug abuse.