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Sponsored by: |
AJI Pharma USA |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002098 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded within 1 month prior to study entry:
Prior Treatment:
Excluded:
United States, California | |
ViRx Inc | |
San Francisco, California, United States, 94109 | |
United States, Florida | |
Goodgame Med Group | |
Maitland, Florida, United States, 32751 |
Study Chair: | Lang W | |
Study Chair: | Goodgame J |
Study ID Numbers: | 126A, 91-10-15 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002098 |
Health Authority: | United States: Food and Drug Administration |
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Lentinan |
Virus Diseases Sexually Transmitted Diseases, Viral Didanosine HIV Seropositivity HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Lentinan Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Adjuvants, Immunologic Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |