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Viral Activation Transfusion Study (VATS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000593
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
October 27, 1999
October 28, 1999
July 12, 2016
November 1994
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Complete list of historical versions of study NCT00000593 on ClinicalTrials.gov Archive Site
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Viral Activation Transfusion Study (VATS)
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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.

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 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).

Interventional
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Allocation: Randomized
Primary Purpose: Prevention
  • Acquired Immunodeficiency Syndrome
  • Blood Transfusion
  • Cytomegalovirus Infections
  • HIV Infections
Procedure: blood transfusion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2001
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HIV-infected patients with CD4 counts below 250 who clinically needed red blood cell transfusions.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000593
313
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Leslie Kalish New England Research Institute, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP