A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

NCT00002007 | Completed

• 2 other identifiers: 067C202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.

Conditions

HIV Infections; Cytopenias

Keywords

Leukopenia; Granulocyte-Macrophage Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Zidovudine DRUG

Sargramostim DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• Serum antibody to HIV with or without evidence of HIV antigenemia.
• White blood cells (WBC) = or \< 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
• Qualifying indications for AZT therapy.
• Life expectancy = or \> 6 months.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Current or past history of malignancy including Kaposi's sarcoma.
• Excessive diarrhea or significant malabsorption.
• If patients have had \> 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene \< 75 IU/ml, serum vitamin A \< 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
• Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
• Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
• Active OI requiring systemic treatment.
• Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.
• Concurrent Medication:
• Excluded within 4 weeks of study entry:
• Zidovudine (AZT).
• Other antiviral agent associated with leukopenia.
• Investigational drug.
• Immunomodulators.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Natl Cancer Institute

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

HIV Infections; Cytopenia; Leukopenia; Acquired Immunodeficiency Syndrome

Interventions

Zidovudine; sargramostim

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1990-01

Locations

US (1)