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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002099
• Other study ID #: 126B
• Secondary ID: 92-11-9
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1994
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients are treated with daily oral ddI for 6 weeks, then are randomized to ddI in combination with intravenous lentinan or placebo (administered once weekly) for 26 weeks. Patients who are already stabilized on 400 mg/day ddI will proceed directly to randomization. Following completion of the combination therapy, patients may be offered 26 additional weeks of therapy on an optional basis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 IV drug abuse.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lentinan

• Didanosine

Locations

Country	Name	City	State
United States	HIV Research Group	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
AJI Pharma USA

Country where clinical trial is conducted

United States,