Viral Activation Transfusion Study (VATS)

NCT00000593 | Completed

• 1 other identifier: 313
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acquired Immunodeficiency Syndrome; Blood Transfusion; Cytomegalovirus Infections; HIV Infections

Interventions

blood transfusion PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

HIV-infected patients with CD4 counts below 250 who clinically needed red blood cell transfusions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (16)

• Busch MP, Collier A, Gernsheimer T, Carrington JD, Flanigan TP, Kashkari M, Kennedy M, Kumar PN, Lane TA, Mellors JW, Mohandas K, Pollard RB, Viele M, Yomtovian R, Holland PV, McCurdy PR. The Viral Activation Transfusion Study (VATS): rationale, objectives, and design overview. Transfusion. 1996 Oct;36(10):854-9. doi: 10.1046/j.1537-2995.1996.361097017169.x. No abstract available.

  PMID: 8863770 BACKGROUND

• Lee TH, Sakahara NS, Fiebig EW, Hirschkorn DF, Johnson DK, Busch MP. Quantitation of white cell subpopulations by polymerase chain reaction using frozen whole-blood samples. Viral Activation Transfusion Study. Transfusion. 1998 Mar;38(3):262-70. doi: 10.1046/j.1537-2995.1998.38398222870.x.

  PMID: 9563406 BACKGROUND

• Kalish LA, Collier AC, Flanigan TP, Kumar PN. Plasma human immunodeficiency virus (HIV) type 1 RNA load in men and women with advanced HIV-1 disease. J Infect Dis. 2000 Aug;182(2):603-6. doi: 10.1086/315710. Epub 2000 Jul 21.

  PMID: 10915096 BACKGROUND

• Collier AC, Kalish LA, Busch MP, Gernsheimer T, Assmann SF, Lane TA, Asmuth DM, Lederman MM, Murphy EL, Kumar P, Kelley M, Flanigan TP, McMahon DK, Sacks HS, Kennedy MS, Holland PV; Viral Activation Transfusion Study Group. Leukocyte-reduced red blood cell transfusions in patients with anemia and human immunodeficiency virus infection: the Viral Activation Transfusion Study: a randomized controlled trial. JAMA. 2001 Mar 28;285(12):1592-601. doi: 10.1001/jama.285.12.1592.

  PMID: 11268267 BACKGROUND

• Lane TA, Gernsheimer T, Mohandas K, Assmann SF. Signs and symptoms associated with the transfusion of WBC-reduced RBCs and non-WBC-reduced RBCs in patients with anemia and HIV infection: results from the Viral Activation Transfusion Study. Transfusion. 2002 Feb;42(2):265-74. doi: 10.1046/j.1537-2995.2002.00036.x.

  PMID: 11896345 BACKGROUND

• Brecher ME, Triulzi DJ, Assmann SF; Viral Activation Transfusion Study. Number of RBC units and rate of transfusionto anemic HIV-positive patients assigned to receiveWBC-reduced or non-WBC-reduced RBCs: the viral activation transfusion study experience. Transfusion. 2001 Jun;41(6):794-8. doi: 10.1046/j.1537-2995.2001.41060794.x.

  PMID: 11399822 BACKGROUND

• Kennedy MS, Kalish LA, Mohandas K, Gernsheimer T, Townsend-McCall D; Viral Activation Transfusion Study Group. The transfusion trigger and number of units transfused in patients with HIV: associations with disease stage and functional status. Transfusion. 2002 Apr;42(4):456-61. doi: 10.1046/j.1525-1438.2002.00081.x.

  PMID: 12076293 BACKGROUND

• Asmuth DM, Kalish LA, Laycock ME, Murphy EL, Mohr BA, Lee TH, Gallarda J, Giachetti C, Dollard SC, van der Horst CM, Grant RM, Busch MP; Viral Activation Transfusion Study Group. Absence of HBV and HCV, HTLV-I and -II, and human herpes virus-8 activation after allogeneic RBC transfusion in patients with advanced HIV-1 infection. Transfusion. 2003 Apr;43(4):451-8. doi: 10.1046/j.1537-2995.2003.00350.x.

  PMID: 12662277 BACKGROUND

• Ariga H, Lee TH, Laycock ME, Mohr BA, Kalish LA, Yomtovian R, Gernsheimer T, Busch MP; Viral Activation Transfusion Study. Residual WBC subsets in filtered prestorage RBCs. Transfusion. 2003 Jan;43(1):98-106. doi: 10.1046/j.1537-2995.2003.00270.x.

  PMID: 12519437 BACKGROUND

• Drew WL, Chou S, Miner RC, Mohr BA, Busch MP, van der Horst CM, Asmuth DM, Kalish LA. Cytomegalovirus glycoprotein B groups in human immunodeficiency virus-infected patients with incident retinitis. J Infect Dis. 2002 Jul 1;186(1):114-7. doi: 10.1086/341071. Epub 2002 May 22.

  PMID: 12089671 BACKGROUND

• Eisenbud R, Assmann SF, Kalish LA, van Der Horst C, Collier AC; Viral Activation Transfusion Study Group. Differences in difficulty adjudicating clinical events in patients with advanced HIV disease. J Acquir Immune Defic Syndr. 2001 Sep 1;28(1):43-6. doi: 10.1097/00042560-200109010-00007.

  PMID: 11579276 BACKGROUND

• Yomtovian R, Gernsheimer T, Assmann SF, Mohandas K, Lee TH, Kalish LA, Busch MP; Viral Activation Transfusion Study Group. WBC reduction in RBC concentrates by prestorage filtration: multicenter experience. Transfusion. 2001 Aug;41(8):1030-6. doi: 10.1046/j.1537-2995.2001.41081030.x.

  PMID: 11493735 BACKGROUND

• Kruskall MS, Lee TH, Assmann SF, Laycock M, Kalish LA, Lederman MM, Busch MP; Viral Activation Transfusion Study Group. Survival of transfused donor white blood cells in HIV-infected recipients. Blood. 2001 Jul 15;98(2):272-9. doi: 10.1182/blood.v98.2.272.

  PMID: 11435293 BACKGROUND

• Murphy EL, Collier AC, Kalish LA, Assmann SF, Para MF, Flanigan TP, Kumar PN, Mintz L, Wallach FR, Nemo GJ; Viral Activation Transfusion Study Investigators. Highly active antiretroviral therapy decreases mortality and morbidity in patients with advanced HIV disease. Ann Intern Med. 2001 Jul 3;135(1):17-26. doi: 10.7326/0003-4819-135-1-200107030-00005.

  PMID: 11434728 BACKGROUND

• Para MF, Kalish LA, Collier AC, Murphy EL, Drew WL; Viral Activation Transfusion Study Group. Correlates of change in cytomegalovirus viremia in patients with advanced human immunodeficiency virus infection who require transfusion. J Infect Dis. 2001 Jun 1;183(11):1673-7. doi: 10.1086/320702. Epub 2001 Apr 27.

  PMID: 11343218 BACKGROUND

• Para MF, Kalish LA, Collier AC, Pollard RB, Kumar PN, Mintz L, Wallach FR, Drew WL; Viral Activation Transfusion Study (VATS) Group. Qualitative and quantitative PCR measures of cytomegalovirus in patients with advanced HIV infection who require transfusions. J Acquir Immune Defic Syndr. 2001 Apr 1;26(4):320-5. doi: 10.1097/00126334-200104010-00004.

  PMID: 11317072 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cytomegalovirus Infections; HIV Infections

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Leslie Kalish

  New England Research Institute, Inc.

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: November 1, 1994
• Study Completion: March 1, 2001
• Last Updated: July 12, 2016

Record last verified: 2005-12