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

NCT00002098 | Completed Phase 1

• 2 other identifiers: 126A91-10-15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

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

Interventions

Lentinan DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Thyroxine.
• Concurrent Treatment:

Sponsors & Collaborators

• AJI Pharma USA: lead

Study Sites (2)

ViRx Inc

San Francisco, California, 94109, United States

Location

Goodgame Med Group

Maitland, Florida, 32751, United States

Location

Related 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.

  PMID: 8721897 BACKGROUND

• 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)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Lentinan; Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

beta-Glucans; Glucans; Polysaccharides; Carbohydrates; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Lang W

  STUDY CHAIR

• Goodgame J

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1995-03

Locations

US (2)