Trial | NCT00002098  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
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.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Lentinan

Drug Didanosine

Criteria 

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 drug abuse.
No Results Posted