Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006578
Status:
WITHDRAWN
Last Update Posted:
2015-03-09
First Post:
2000-12-01
Brief Title:
Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Relationship Between Immunologic Recovery After Highly Active Antiretroviral Therapy and the Ability to Mobilize CD34 Stem Cells Following G-CSF Administration
Status:
WITHDRAWN
Status Verified Date:
2003-06
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 if the amount of stem cells cells that can develop into many kinds of cells in the blood before anti-HIV drugs are taken can predict if the immune system will become stronger after anti-HIV drugs are given and if anti-HIV drugs can restore stem cells
HIV infection has been shown to cause stem cells not to function well Granulocyte colony-stimulating factor G-CSF which causes stem cells to go from the bone marrow tissues in the bones where blood cells are formed into the bloodstream could possibly help boost immunity after anti-HIV treatment This study examines the effects of G-CSF in helping the immune system become stronger after beginning anti-HIV treatment
HIV infection has been shown to cause stem cells not to function well Granulocyte colony-stimulating factor G-CSF which causes stem cells to go from the bone marrow tissues in the bones where blood cells are formed into the bloodstream could possibly help boost immunity after anti-HIV treatment This study examines the effects of G-CSF in helping the immune system become stronger after beginning anti-HIV treatment
Detailed Description:
In HIV infection a progressive decline andor dysfunction of several cell types is seen It is thought that stem cell dysfunction or destruction may contribute to the hematologic and immunologic perturbations characteristic of HIV infection and may possibly limit the extent of immunologic recovery following HAART This study proposes to investigate whether stem cell function and reserves are important in determining the extent of immune reconstitution following HAART
Patients are stratified according to CD4 count On Day 0 patients receive a 7-day cycle of subcutaneous granulocyte colony-stimulating factor G-CSF Blood samples are collected regularly and on Day 14 patients undergo real-time HIV-1 RNA determinations On Day 28 or sooner if HIV RNA is at least 1 log above baseline on Day 14 HAART consisting of daily receipt of abacavir lamivudine amprenavir and ritonavir is initiated and continues until Week 76 Patients who achieve viral suppression below 400 copiesml of plasma HIV-1 RNA by Week 26 are eligible to receive a second 7-day cycle of G-CSF at Week 28 and if viral suppression continues through Week 50 a third cycle of G-CSF at Week 52 Patients are followed every 8 weeks for changes in viral load Additionally patients are monitored at regular intervals for surrogate markers of immunologic recovery and during each cycle of G-CSF for measurements of stem cell mobilization Patients may also volunteer for A5085s Bone Marrow Aspirate Substudy at participating sites
Patients are stratified according to CD4 count On Day 0 patients receive a 7-day cycle of subcutaneous granulocyte colony-stimulating factor G-CSF Blood samples are collected regularly and on Day 14 patients undergo real-time HIV-1 RNA determinations On Day 28 or sooner if HIV RNA is at least 1 log above baseline on Day 14 HAART consisting of daily receipt of abacavir lamivudine amprenavir and ritonavir is initiated and continues until Week 76 Patients who achieve viral suppression below 400 copiesml of plasma HIV-1 RNA by Week 26 are eligible to receive a second 7-day cycle of G-CSF at Week 28 and if viral suppression continues through Week 50 a third cycle of G-CSF at Week 52 Patients are followed every 8 weeks for changes in viral load Additionally patients are monitored at regular intervals for surrogate markers of immunologic recovery and during each cycle of G-CSF for measurements of stem cell mobilization Patients may also volunteer for A5085s Bone Marrow Aspirate Substudy at participating sites
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 |
|---|---|---|---|
| Substudy ACTG A5085s | None | None | None |
| AACTG A5072 | None | None | None |