Search / Trial NCT00000850

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

Trial Information

Current as of December 05, 2024

Completed

Keywords

Hiv 1 Granulocyte Macrophage Colony Stimulating Factor Rna, Viral Anti Hiv Agents Viral Load Receptors, Chemokine

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...

Gender

ALL

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.

Trial Officials

Jeffrey Jacobson

Study Chair

Gail Skowron

Study Chair

Pablo Tebas

Study Chair

Hernan Valdez

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Birmingham, Alabama, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

New York, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, United States

Torrance, California, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Boston, Massachusetts, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Los Angeles, California, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Indianapolis, Indiana, United States

Los Angeles, California, United States

Menlo Park, California, United States

San Rafael, California, United States

New York, New York, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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