A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Completed · Phase 1

Conditions studied: HIV Infections, Cytopenias

In brief

To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.

Key facts

Study ID

NCT00002006

Run by

Sandoz

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Treatment:
• Allowed:
• Minimal local irradiation for tumors.
• Patients must have:
• Diagnosis of AIDS or AIDS related complex (ARC).
• Neutropenia, due either to zidovudine (AZT) or HIV infection.
• Life expectancy = or > 6 months.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following:
• Serum carotene less than 75 IU/ml.
• Vitamin A level less than 75 IU/ml.
• More than 4 foul-smelling or greasy stools per day.
• Other criteria of malabsorption.
• Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation.
• Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection.
• Concurrent Medication:
• Excluded within 4 weeks of study entry:
• Any investigational drug.
• Immunomodulating agents.
• Hormonal therapy.
• Cytolytic chemotherapeutic agents.
• Antiretroviral agent other than zidovudine (AZT).
• Excluded within 4 months of study entry:
• Suramin.
• Excluded within 3 months of study entry:
• Ribavirin.
• Patients with the following are excluded:
• Significant malabsorption.
• Tumor likely to require specific antitumor therapy during study.
• Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions.
• Uncorrected nutritional deficiencies that may contribute to neutropenia.

Where it is running

• Natl Cancer Institute — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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