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Phase I/II Study of Curdlan Sulfate

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ClinicalTrials.gov Identifier: NCT00002100
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

November 2, 1999
August 31, 2001
June 24, 2005
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No Changes Posted
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Phase I/II Study of Curdlan Sulfate
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.)
Interventional
Phase 1
Primary Purpose: Treatment
HIV Infections
Drug: Curdlan sulfate
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002100
127A
LCPL 92-1-28
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AJI Pharma USA
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NIH AIDS Clinical Trials Information Service
April 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP