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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


N/A
6 Months
12 Years
Not Enrolling
Both
HIV Infections, Cytopenias

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Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

067B

NCT ID:

NCT00002263

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Cytopenias
  • Pilot Projects
  • Neutropenia
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Neutropenia

Name

Location

Natl Cancer Institute / HIV / AIDS Malignancy BranchBethesda, Maryland  20892