Phase I/II Study of Curdlan Sulfate

AJI Pharma

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Curdlan sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002100

127A

LCPL 92-1-28

Details and patient eligibility

About

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.

Full description

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.)

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.