- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002099
Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
June 23, 2005 updated by: AJI Pharma USA
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.
Study Overview
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92102
- HIV Research Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Pearce D
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
July 1, 1994
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- HIV Seropositivity
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Didanosine
- Lentinan
Other Study ID Numbers
- 126B
- 92-11-9
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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