Phase I/II Study of Curdlan Sulfate - Full Text View

Sponsor:	AJI Pharma USA
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002100

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Curdlan sulfate	Phase I

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Safety Study
Official Title:	Phase I/II Study of Curdlan Sulfate

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Curdlan sulfate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed 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.)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002100

Locations

United States, California
ViRx Inc
San Francisco, California, United States, 94109

Sponsors and Collaborators

AJI Pharma USA

More Information

Publications:

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.

Study ID Numbers:	127A, LCPL 92-1-28
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002100 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
curdlan sulfate

Additional relevant MeSH terms:

Curdlan sulfate
Anti-Infective Agents
Antiprotozoal Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Antimalarials
Antiparasitic Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009