Viral Activation Transfusion Study (VATS)
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|ClinicalTrials.gov Identifier: NCT00000593|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : July 12, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome Blood Transfusion Cytomegalovirus Infections HIV Infections||Procedure: blood transfusion||Not Applicable|
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.
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 don't 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 don't 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 Type :||Interventional (Clinical Trial)|
|Study Start Date :||November 1994|
|Actual Study Completion Date :||March 2001|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000593
|OverallOfficial:||Leslie Kalish||New England Research Institute, Inc.|
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
|Other Study ID Numbers:||
|First Posted:||October 28, 1999 Key Record Dates|
|Last Update Posted:||July 12, 2016|
|Last Verified:||December 2005|
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections