- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002008
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
June 23, 2005 updated by: Sandoz
To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA CARE Ctr
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - West Campus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
January 1, 1989
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 067D
- 106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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