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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Page 1 of 10 (39 locations)

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