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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to see how HIV-positive patients who are taking anti-HIV drugs and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to GM-CSF (granulocyte-macrophage colony-stimulating factor). GM-CSF is a medication that is being tested in HIV-positive patients to see if it can improve their immune systems or if it can lower the level of HIV in their blood. GM-CSF is often given to patients with leukemia or patients who have received bone marrow transplants to increase their white blood cells and to improve their immune systems. Doctors believe that GM-CSF can increase CD4 counts in HIV-positive patients, but this study will also look at how GM-CSF affects viral load.

Key facts

Study ID

NCT00000850

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

108

Expected to finish

2003-12-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Kaiser Permanente LAMC — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Willow Clinic — Menlo Park, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
• Marin County Specialty Clinic — San Rafael, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Boston Med Ctr — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• St Louis Regional Hosp / St Louis Regional Med Ctr — St Louis, Missouri, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ — New York, New York, United States

Full record on ClinicalTrials.gov

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