NCT00002098CompletedPhase 1
Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
AJI Pharma USA4 sites in 1 country50 target enrollmentStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 4
Study Overview
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.
Detailed Description
Patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in combination with ddI for at least 26 weeks; those tolerating their dose may be offered continuation of therapy for an additional 26 weeks.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have:
- •HIV seropositivity.
- •Absolute CD4 count of 200 - 500 cells/mm
- •No active opportunistic infection or Kaposi's sarcoma.
- •Prior Medication:
- •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:
- •Antiretroviral agents other than ddI.
- •Steroids.
- •Cytotoxic agents.
- •Immunosuppressive agents.
- •Immunomodulators.
- •1-Thyroxine.
- •Concurrent Treatment:
- •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:
- •Radiotherapy within 1 month prior to study entry. Active drug abuse.
Investigators
Study Sites (4)
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