Status:
COMPLETED
The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-...
Detailed Description
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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00000850
End Date
December 1 2003
Last Update
October 29 2021
Active Locations (39)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Kaiser Permanente LAMC
Los Angeles, California, United States, 90027
3
UCLA CARE Ctr
Los Angeles, California, United States, 90095
4
Willow Clinic
Menlo Park, California, United States, 94025