The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

GM-CSF promotes the differentiation and activation of granulocytes, monocytes, macrophages, and dendritic cells and enhances the function of these cells. The various cellular responses (i.e., division, maturation, activation) are induced when GM-CSF binds to specific receptors expressed on the surface of target cells. At higher doses, such as the dose used in this protocol, GM-CSF may result in a rapid rise in white blood cell count. However, further research is necessary to determine the potential antiviral effect of GM-CSF in a potent ART-treated population. It is hoped that GM-CSF can de...

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Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this study if they:
• • Are HIV-positive.
• • Have a stable viral load of at least 1,500 copies/ml within 30 days of study entry.
• • Are on stable aggressive anti-HIV therapy for at least 8 weeks before study entry and intend to remain on this therapy during the study.
• • Agree to learn how to give themselves the GM-CSF shots.
• • Agree to practice acceptable barrier methods of birth control (such as condoms) during the study and for at least 12 weeks after treatment ends.
• • Are at least 18 years old.
• • Exclusion Criteria
• Patients will not be eligible for this study if they:
• • Have an infection or other illness within 14 days of study entry.
• • Have certain types of hepatitis within 30 days of study entry.
• • Have a fever or chronic diarrhea within 30 days of study entry.
• • Have cancer (except for certain types of Kaposi's sarcoma).
• • Have heart disease.
• • Are allergic to GM-CSF.
• • Have received certain medications.
• • Are pregnant or breast-feeding.