Phase I/II Study of Curdlan Sulfate

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single doses and then, after FDA review, daily doses for 7 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AJI Pharma USA
• Treatments: Curdlan sulfate

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.