Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AJI Pharma USA
Treatments:
Didanosine
Lentinan
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.