An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Launched by SANDOZ · Aug 30, 2001
Trial Information
Current as of July 01, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
MALE
Eligibility criteria
- • Inclusion Criteria
- Patients must have:
- • Serum antibody to HIV with or without evidence of HIV.
- • Antigenemia.
- • Anticipated survival of at least 6 months.
- * Allowed:
- • Kaposi's sarcoma.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- • Malignancy other than Kaposi's sarcoma.
- • Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
- • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.
- • Primary hematologic or infectious disorders unrelated to AIDS virus infection.
- • Dementia or altered mental status that would prohibit the giving and understanding of informed consent.
- Patients with the following are excluded:
- • History of malignancy other than Kaposi's sarcoma.
- • Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.
- Prior Medication:
- Excluded within 3 weeks of study entry:
- • Marrow suppressive medication.
- * Excluded within 4 weeks of study entry:
- • Any investigational drug.
- Prior Treatment:
- Excluded within 4 weeks of study entry:
- • Systemic cytotoxic chemotherapy.
- • Irradiation.
- Risk Behavior:
- Excluded within 3 months of study entry:
- • Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.
About Sandoz
Sandoz, a global leader in generic pharmaceuticals and biosimilars, is committed to advancing healthcare by providing high-quality, affordable medications that enhance patient access to essential treatments. As a division of Novartis, Sandoz leverages innovative research and development to deliver a diverse portfolio of products across various therapeutic areas, including oncology, immunology, and cardiovascular health. The company prioritizes rigorous clinical trials to ensure the safety and efficacy of its offerings, fostering collaboration with healthcare professionals and regulatory bodies to meet the evolving needs of patients worldwide. Through its dedication to quality and sustainability, Sandoz aims to improve health outcomes and contribute to more efficient healthcare systems globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Los Angeles, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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