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.
Patients are stratified at study entry according to screening CD4 count (below 200 cells/mm3
versus 200 cells/mm3 or higher) and screening HIV-1 RNA copy number (between 1,500 and 10,000
versus 10,000 copies/ml or higher). Then, patients are randomized to receive GM-CSF or GM-CSF
placebo subcutaneously 3 times per week for 16 weeks. All patients remain on their current
stable potent ART (not provided by this study). During Step 2, all patients receive
open-label study treatment, consisting of current potent ART plus GM-CSF subcutaneously 3
times per week for 32 additional weeks. HIV-1 RNA, CD4 counts, and clinical and safety
parameters are monitored for all patients periodically until Week 52. Patients who experience
an increase in HIV-1 RNA of greater than 1 log 10 from baseline on 2 consecutive
determinations or a greater than 50% decrease in CD4 count from baseline (a drop of at least
50 cells) on 2 consecutive determinations at any time during Step 1 or 2 must discontinue all
study treatment. Patients who discontinue study treatment for any reason prior to Week 16
continue following the study visit schedule through Week 16.
Additional laboratory samples are performed on patients participating in the immunology
substudy (ACTG A5042s) in order to further evaluate the effects of GM-CSF on immune
function.
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.
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States
San Francisco Gen Hosp, San Francisco, California 941102859, United States
Stanford Univ Med Ctr, Stanford, California 943055107, United States
UCLA CARE Ctr, Los Angeles, California 90095, United States
Harbor UCLA Med Ctr, Torrance, California 90502, United States
San Mateo AIDS Program / Stanford Univ, Stanford, California 943055107, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California 951282699, United States
Marin County Specialty Clinic, San Rafael, California 94903, United States
Willow Clinic, Menlo Park, California 94025, United States
Kaiser Permanente LAMC, Los Angeles, California 90027, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Univ of Hawaii, Honolulu, Hawaii 96816, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana 46202, United States
Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Beth Israel Deaconess - West Campus, Boston, Massachusetts 02215, United States
Boston Med Ctr, Boston, Massachusetts 02118, United States
St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis, Missouri 63112, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Cornell Univ Med Ctr, New York, New York 10021, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York, New York 10021, United States
Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Chelsea Ctr, New York, New York 10021, United States
Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States
Duke Univ Med Ctr, Durham, North Carolina 27710, United States
Case Western Reserve Univ, Cleveland, Ohio 44106, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
MetroHealth Med Ctr, Cleveland, Ohio 441091998, United States
Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania 19104, United States
Philadelphia Veterans Administration Med Ctr, Philadelphia, Pennsylvania 19104, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Univ of Texas Galveston, Galveston, Texas 775550435, United States
Univ of Washington, Seattle, Washington 98104, United States
