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

Sponsor:	Sandoz Inc.
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002007

Purpose

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.

Condition	Intervention
HIV Infections Cytopenias	Drug: Zidovudine Drug: Sargramostim

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
Interferon.
Steroids.
Excluded within 8 weeks of study entry:
Ribavirin.
Excluded within 4 months of study entry:
Suramin.

Patients with the following are excluded:

Current or past history of malignancy including Kaposi's sarcoma.
Excessive diarrhea or significant malabsorption.
Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).
Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Prior Medication:

Excluded:

Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.

Risk Behavior:

Excluded:

Current drug or alcohol abusers.
Unprotected sexual contact or other activities that may result in reinfection with HIV.

Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002007

Locations

United States, Maryland
Natl Cancer Institute
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Sandoz Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002007 History of Changes
Other Study ID Numbers:	067C, 202
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Leukopenia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Leukocyte Disorders

Hematologic Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012