Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
Recruitment status was Active, not recruiting
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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 2 |
| 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 |
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 |
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 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 May 21, 2013