Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AJI Pharma USA
Patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in combination with ddI for at least 26 weeks; those tolerating their dose may be offered continuation of therapy for an additional 26 weeks.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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 drug abuse.
Clareo Health | Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
