A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
NCT ID: NCT00002009
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Sargramostim
Eligibility Criteria
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Inclusion Criteria
* Met the CDC criteria for the diagnosis of AIDS.
* Total peripheral blood leukocyte count = or \< 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
* Must have or have recovered from one or more opportunistic infection.
* Serum antibody to HTLV-III/LAV with or without viremia.
* Anticipated survival of at least 6 months.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* AIDS related complex (ARC).
* History of malignancy other than Kaposi's sarcoma (KS).
* 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 infections.
* Presence of renal dysfunction.
* Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.
Patients with the following are excluded:
* AIDS related complex (ARC).
* History of malignancy other than Kaposi's sarcoma (KS).
* 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 an opportunistic infection.
* Dementia or altered mental status that would prohibit the giving and understanding of informed consent.
Prior Medication:
Excluded:
* Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
* Excluded within 6 weeks of study entry:
* Any investigational drug.
Prior Treatment:
Excluded within 6 weeks of study entry:
* Systemic cytotoxic chemotherapy or irradiation.
Risk Behavior:
Excluded within 3 months of study entry:
* Regular, excessive use of alcohol, hallucinogens or agents which are addicting.
18 Years
50 Years
MALE
No
Sponsors
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Sandoz
INDUSTRY
Locations
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UCLA CARE Ctr
Los Angeles, California, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Countries
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References
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Barbarini G, Garavelli G, Grisorio B, Barbaro G, Giangregorio F. GM-CSF in HIV related leukopenia: efficacy and tolerability of three months therapy on 50 patients. Int Conf AIDS. 1996 Jul 7-12;11(1):313 (abstract no TuB2279)
Other Identifiers
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101
Identifier Type: -
Identifier Source: secondary_id
067E
Identifier Type: -
Identifier Source: org_study_id