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
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
January 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (1)
Natl Cancer Institute
Bethesda, Maryland, 20892, United States
Related Publications (1)
Levine JD, Allan JD, Tessitore JH, Falcone N, Galasso F, Israel RJ, Groopman JE. Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome (AIDS)/AIDS-related complex. Blood. 1991 Dec 15;78(12):3148-54.
PMID: 1742482BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-01