An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

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 determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.

Detailed Description

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Conditions

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HIV Infections Cytopenias

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sargramostim

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* Serum antibody to HIV with or without evidence of HIV.
* Antigenemia.
* Anticipated survival of at least 6 months.
* Allowed:
* Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Malignancy other than Kaposi's sarcoma.
* Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.
* Primary hematologic or infectious disorders unrelated to AIDS virus infection.
* Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Patients with the following are excluded:

* History of malignancy other than Kaposi's sarcoma.
* Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.

Prior Medication:

Excluded within 3 weeks of study entry:

* Marrow suppressive medication.
* Excluded within 4 weeks of study entry:
* Any investigational drug.

Prior Treatment:

Excluded within 4 weeks of study entry:

* Systemic cytotoxic chemotherapy.
* Irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

* Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Locations

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UCLA CARE Ctr

Los Angeles, California, United States

Site Status

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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106

Identifier Type: -

Identifier Source: secondary_id

067D