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

Launched by SANDOZ · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.
• • Hypersensitivity to zidovudine (AZT) or other nucleoside analogs.
• • Profound dementia or altered mental status that would prohibit the giving of informed consent.
• Prior Treatment:
• Excluded within 1 month of study entry:
• • Transfusion.
• * Excluded within 4 weeks of study entry:
• • Radiation therapy to greater than 100 cm2 body area.
• • Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study.
• • Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.