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

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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-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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Indinavir; Sargramostim

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.