Phase I/II Study of Curdlan Sulfate

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Curdlan sulfate

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, curdlan sulfate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

ViRx Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002100

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

AJI Pharma USA

1. Study Identification

Unique Protocol Identification Number

NCT00002100

Brief Title

Phase I/II Study of Curdlan Sulfate

Official Title

Phase I/II Study of Curdlan Sulfate

Study Type

Interventional

2. Study Status

Record Verification Date

April 1994

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

AJI Pharma USA

4. Oversight

5. Study Description

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.

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, curdlan sulfate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Curdlan sulfate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

ViRx Inc

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

7996061

Citation

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.

Results Reference

background

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial