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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002098

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Lentinan

Brief 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.

Detailed description

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.

Interventions

DRUGLentinan

DRUGDidanosine

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026