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Trial NCT00000593

Resource URI: http://static.linkedct.org/resource/trials/NCT00000593
PropertyValue
linkedct:brief_title Viral Activation Transfusion Study (VATS)
linkedct:condition <http://static.linkedct.org/resource/condition/1725>
linkedct:condition <http://static.linkedct.org/resource/condition/208>
linkedct:condition <http://static.linkedct.org/resource/condition/3545>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria HIV-infected patients with CD4 counts below 250 who clinically needed red blood cell transfusions.
linkedct: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 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 2001
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000593
rdfs:label Trial NCT00000593
linkedct:lastchanged_date January 3, 2006
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000593
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 313
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/35024>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000593>
linkedct:phase N/A
linkedct:reference <http://static.linkedct.org/resource/reference/10062>
linkedct:reference <http://static.linkedct.org/resource/reference/10416>
linkedct:reference <http://static.linkedct.org/resource/reference/10589>
linkedct:reference <http://static.linkedct.org/resource/reference/10594>
linkedct:reference <http://static.linkedct.org/resource/reference/10910>
linkedct:reference <http://static.linkedct.org/resource/reference/11378>
linkedct:reference <http://static.linkedct.org/resource/reference/12912>
linkedct:reference <http://static.linkedct.org/resource/reference/13854>
linkedct:reference <http://static.linkedct.org/resource/reference/13945>
linkedct:reference <http://static.linkedct.org/resource/reference/15943>
linkedct:reference <http://static.linkedct.org/resource/reference/16814>
linkedct:reference <http://static.linkedct.org/resource/reference/50813>
linkedct:reference <http://static.linkedct.org/resource/reference/54237>
linkedct:reference <http://static.linkedct.org/resource/reference/7696>
linkedct:reference <http://static.linkedct.org/resource/reference/9637>
linkedct:reference <http://static.linkedct.org/resource/reference/9921>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date November 1994
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date December 2005