Phase I/II Study of Curdlan Sulfate

Launched by AJI PHARMA USA · Aug 30, 2001

Keywords

ClinConnect Summary

In Phase I of the study, escalating single doses of intravenous curdlan sulfate are tested. In Phase II, curdlan sulfate is administered daily for 7 days. (NOTE: Phase I is completed.)

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV seropositivity.
• • No current AIDS-defining opportunistic infection, lymphoma, Kaposi's sarcoma, or other malignancy.
• • CD4 count \< 500 cells/mm3.
• • No critical illness that would shorten life expectancy to \< 16 weeks.
• • Exclusion Criteria
• Concurrent Medication:
• Excluded:
• • Antiretroviral or other experimental therapies.
• • Anticoagulants.
• • Steroids.
• • Cytotoxic or immunosuppressive agents.
• Concurrent Treatment:
• Excluded:
• • Radiotherapy.
• Patients with the following prior condition are excluded:
• • History of heparin sensitivity.
• Prior Medication:
• Excluded within 1 month prior to study entry:
• • Antiretroviral or other experimental therapies.
• • Anticoagulants.
• • Steroids.
• • Cytotoxic or immunosuppressive agents.
• Prior Treatment:
• Excluded:
• • Radiotherapy within 1 month prior to study entry. Active IV drug abuse.