Phase I/II 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 I/II 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: Completed

Administrative data

• NCT number: NCT00002098
• Other study ID #: 126A
• Secondary ID: 91-10-15
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1995
• 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) 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• 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 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	Goodgame Med Group	Maitland	Florida
United States	ViRx Inc	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
AJI Pharma USA

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gordon M, Guralnik M, Kaneko Y, Mimura T, Goodgame J, DeMarzo C, Pierce D, Baker M, Lang W. A phase II controlled study of a combination of the immune modulator, lentinan, with didanosine (ddI) in HIV patients with CD4 cells of 200-500/mm3. J Med. 1995;26(5-6):193-207. — View Citation

Kaneko Y, Mimura T, Guralnik M, Baker M, Goodgame J, DeMarzo C, Pierce D, Lang W, Gordon M. Phase II study of combination of lentinan with ddI in HIV-positive patients. Int Conf AIDS. 1994 Aug 7-12;10(1):212 (abstract no PB0276)