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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1995

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.

Condition Intervention Phase
HIV Infections
Drug: Lentinan
Drug: Didanosine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 50
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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:


  • 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:


  • Antiretroviral agents other than ddI.
  • Steroids.
  • Cytotoxic agents.
  • Immunosuppressive agents.
  • Immunomodulators.
  • 1-Thyroxine.

Concurrent Treatment:


  • 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:


  • Radiotherapy within 1 month prior to study entry. Active drug abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002098

United States, California
ViRx Inc
San Francisco, California, United States, 94109
United States, Florida
Goodgame Med Group
Maitland, Florida, United States, 32751
Sponsors and Collaborators
AJI Pharma USA
Study Chair: Lang W
Study Chair: Goodgame J
  More Information

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) Identifier: NCT00002098     History of Changes
Other Study ID Numbers: 126A, 91-10-15
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Adjuvants, Immunologic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on October 02, 2015