Phase I/II Study of Curdlan Sulfate

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002100
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1994
  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: Endpoint Classification: Safety Study
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

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
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, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00002100     History of Changes
Other Study ID Numbers: 127A, LCPL 92-1-28
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Curdlan sulfate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents

ClinicalTrials.gov processed this record on September 22, 2014