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Sponsored by: |
Sandoz Inc. |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002007 |
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 |
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HIV Infections Cytopenias |
Drug: Zidovudine Drug: Sargramostim |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison |
Official Title: | A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded within 4 weeks of study entry:
Patients with the following are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.
Study ID Numbers: | 067C, 202 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002007 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukopenia Granulocyte-Macrophage Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Zidovudine |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Hematologic Diseases Acquired Immunodeficiency Syndrome Zidovudine Leukocyte Disorders Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Leukopenia Retroviridae Infections |
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Leukocyte Disorders Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Hematologic Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Leukopenia |