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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 1994 by NIH AIDS Clinical Trials Information Service. Recruitment status was Active, not recruiting

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	AJI Pharma USA
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002099

Purpose

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.

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lentinan Didanosine

U.S. FDA Resources

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

Detailed 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.

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002099

Locations

United States, California
HIV Research Group
San Diego, California, United States, 92102

Sponsors and Collaborators

AJI Pharma USA

Investigators

Study Chair:

Pearce D

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002099 History of Changes
Other Study ID Numbers:	126B, 92-11-9
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:

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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Lentinan
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012