Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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 drug abuse.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | ViRx Inc | San Francisco | California | United States | 94109 |
2 | Goodgame Med Group | Maitland | Florida | United States | 32751 |
Sponsors and Collaborators
- AJI Pharma USA
Investigators
- Study Chair: Lang W,
- Study Chair: Goodgame J,
Study Documents (Full-Text)
None provided.More Information
Publications
- 126A
- 91-10-15