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Phase I/II Study of Curdlan Sulfate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002100
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I/II Study of Curdlan Sulfate

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002100


Locations
United States, California
ViRx Inc
San Francisco, California, United States, 94109
Sponsors and Collaborators
AJI Pharma USA
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002100     History of Changes
Other Study ID Numbers: 127A
LCPL 92-1-28
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: April 1994

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
curdlan sulfate

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Curdlan sulfate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents