Phase I/II Study of Curdlan Sulfate

Official Title: “Phase I/II Study of Curdlan Sulfate”

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.

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.)

Intervention(s) in this Clinical Trial

• Drug: Curdlan sulfate

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AJI Pharma USA Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002100

Study ID Number: 127A

ClinicalTrials.gov Identifier: NCT00002100

Health Authority: United States: Food and Drug Administration