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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) compared 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.

Key facts

Study ID

NCT00002098

Run by

AJI Pharma USA

People needed

50

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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:

Where it is running

• ViRx Inc — San Francisco, California, United States
• Goodgame Med Group — Maitland, Florida, United States

Full record on ClinicalTrials.gov

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