Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000850
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Effects of GM-CSF on Plasma HIV-1 RNA and Chemokine Receptor Expression in HIV-1 Infected Subjects Receiving Concomitant Potent Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1500 copiesml 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
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
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 ie division maturation activation are induced when GM-CSF binds to specific receptors expressed on the surface of target cells At higher doses such as the dose used in this protocol GM-CSF may result in a rapid rise in white blood cell count However further research is necessary to determine the potential antiviral effect of GM-CSF in a potent ART-treated population It is hoped that GM-CSF can decrease the extent of ongoing HIV replication via alteration of macrophage activation and chemokine receptor expression and that this effect can result in reduction of the pool of latently infected T cells
Patients are stratified at study entry according to screening CD4 count below 200 cellsmm3 versus 200 cellsmm3 or higher and screening HIV-1 RNA copy number between 1500 and 10000 versus 10000 copiesml 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
Patients are stratified at study entry according to screening CD4 count below 200 cellsmm3 versus 200 cellsmm3 or higher and screening HIV-1 RNA copy number between 1500 and 10000 versus 10000 copiesml 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5041 | OTHER | ACTG | None |
| AACTG A5041 | None | None | None |
| 10887 | REGISTRY | None | None |