A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine

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

NA

Study Classification

INTERVENTIONAL

Brief Summary

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To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.

Detailed Description

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Conditions

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HIV Infections Cytopenias

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Zidovudine

Intervention Type DRUG

Sargramostim

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT) on NIAID 86-C-175.

Patients must have:

* Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
* Granulocytopenia (\< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.
* Life expectancy \> 3 months.
* Functioning indwelling central venous access device in place.

Prior Medication:

Allowed within 48 hours of study entry:

* Prophylactic antibiotics.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Critically ill or clinically unstable.
* Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.
* Ongoing IV alimentation.
* Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
* Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
* Malignancy likely to require systemic treatment during study.

Patients with the following are excluded:

* Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions.
* Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.

Prior Medication:

Excluded within 48 hours of study entry:

* Antibiotics.
* Excluded within 30 days of study entry:
* Antiretroviral agents other than zidovudine (AZT).
* Acyclovir.
* Ganciclovir.
* Any investigational drug.
* Immunomodulating drugs.
* Cytolytic chemotherapeutic agents.
* Corticosteroids.
* Immunoglobulin preparations.
* Excluded within 4 months of study entry:
* Suramin.

Prior Treatment:

Excluded within 6 months of study entry:

* Bone marrow transplantation.
* Excluded within 4 weeks of study entry:
* Lymphocyte transfusions.
* Radiation therapy.

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Natl Cancer Institute / HIV / AIDS Malignancy Branch

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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206

Identifier Type: -

Identifier Source: secondary_id

067B