Completed
The Effects of GM-CSF on Plasma HIV-1 RNA and Chemokine Receptor Expression in HIV-1 Infected Subjects Receiving Concomitant Potent Antiretroviral Therapy
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
108
Participants Needed
39
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 39 locations
1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status Unknown
2
Kaiser Permanente LAMC
Los Angeles, California, United States, 90027
Status Unknown
3
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
4
Willow Clinic
Menlo Park, California, United States, 94025
Status Unknown
5
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
6
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
7
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Status Unknown
8
Marin County Specialty Clinic
San Rafael, California, United States, 94903
Status Unknown
9
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
10
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
11
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
12
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
13
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
14
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
15
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
16
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
17
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
18
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
19
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Status Unknown
20
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
21
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Status Unknown
22
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Status Unknown
23
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
24
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
25
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
Status Unknown
26
Chelsea Ctr
New York, New York, United States, 10021
Status Unknown
27
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
28
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
29
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
30
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
31
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
32
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
33
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Status Unknown
34
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
35
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
36
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
37
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
38
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Status Unknown
39
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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