NCT00002100

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1994

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency SyndromeAIDS-Related Complexcurdlan sulfate

Interventions

Curdlan sulfateDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ViRx Inc

San Francisco, California, 94109, United States

Location

Related 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.

    PMID: 7996061BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

curdlan sulfate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1994-04

Locations

US(1)