Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000593
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
Viral Activation Transfusion Study VATS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
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 the trial was to determine if transfusion of allogeneic blood to HIV-1 infected persons led to immune activation and consequent induction of HIV-1 or or Cytomegalovirus CMV replication and whether this adversely affected clinical prognosis
Detailed Description:
BACKGROUND
The initiative was approved by the NHLBI AIDS Ad Hoc Working Group and given concept clearance by the September 1993 National Heart Lung and Blood Advisory Council The initiative was released in January 1994
DESIGN NARRATIVE
Patient enrollment started in August 1995 Patients scheduled for transfusion were entered into the study at the time of their first transfusion and randomized to receive leukopoor red cells filtered within 24 hours of collection or unmanipulated blood components Patients received blood as per their treatment arm as needed for one or two years Patients were stratified to those with CD4 counts below 50 MM3 most patients and those with CD4 counts above that level Primary endpoints were overall survival and a change in HIV viremia after the 1st transfusion The secondary endpoint was the occurrence of a new AIDS-defining complication A substudy looked at donor lymphocytes in the immunosuppressed recipients to help determine why AIDS patients dont seem to get post-transfusion graft-vs-host disease The patient recruitment time was extended for one year because of low accrual With new drugs especially protease inhibitors the proportion of patients needing transfusion has decreased The patients are less severely ill and their disease produces less anemia Furthermore the new drugs dont have anemia as a side effect The trial ended in January 2000
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
The initiative was approved by the NHLBI AIDS Ad Hoc Working Group and given concept clearance by the September 1993 National Heart Lung and Blood Advisory Council The initiative was released in January 1994
DESIGN NARRATIVE
Patient enrollment started in August 1995 Patients scheduled for transfusion were entered into the study at the time of their first transfusion and randomized to receive leukopoor red cells filtered within 24 hours of collection or unmanipulated blood components Patients received blood as per their treatment arm as needed for one or two years Patients were stratified to those with CD4 counts below 50 MM3 most patients and those with CD4 counts above that level Primary endpoints were overall survival and a change in HIV viremia after the 1st transfusion The secondary endpoint was the occurrence of a new AIDS-defining complication A substudy looked at donor lymphocytes in the immunosuppressed recipients to help determine why AIDS patients dont seem to get post-transfusion graft-vs-host disease The patient recruitment time was extended for one year because of low accrual With new drugs especially protease inhibitors the proportion of patients needing transfusion has decreased The patients are less severely ill and their disease produces less anemia Furthermore the new drugs dont have anemia as a side effect The trial ended in January 2000
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
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?: