Phase I/II Study of Curdlan Sulfate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.)

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Curdlan sulfate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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ViRx Inc

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 7996061 (View on PubMed)

Other Identifiers

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LCPL 92-1-28

Identifier Type: -

Identifier Source: secondary_id

127A