Phase I/II Study of Curdlan Sulfate

HIV Infections Clinical Trial

Official title:

Phase I/II Study of Curdlan Sulfate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002100
• Other study ID #: 127A
• Secondary ID: LCPL 92-1-28
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1994
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Curdlan sulfate

Locations

Country	Name	City	State
United States	ViRx Inc	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
AJI Pharma USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gordon M, Guralnik M, Kaneko Y, Mimura T, Baker M, Lang W. A phase I study of curdlan sulfate--an HIV inhibitor. Tolerance, pharmacokinetics and effects on coagulation and on CD4 lymphocytes. J Med. 1994;25(3-4):163-80. — View Citation