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Acquired Immunodeficiency SyndromeNCT00000593

Viral Activation Transfusion Study (VATS)

A study testing blood transfusion in people with Acquired Immunodeficiency Syndrome and Blood Transfusion, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
blood transfusion
Type of treatment
Surgery or procedure
How many people
Not given
Where
No sites listed yet
Study dates
Nov 1994to Mar 2001
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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.

Read the 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 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).

Being tested
blood transfusion
Medical subject headings
Acquired Immunodeficiency Syndrome, Cytomegalovirus Infections, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood transfusionProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startNov 1994
  3. Study completionMar 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000593
Sponsor's protocol ID
313
Status last verified
Dec 2005
First submitted
27 Oct 1999
Last updated
12 Jul 2016
Results posted
No

Publications

  • 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.

    PubMed 8863770

  • 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.

    PubMed 9563406

  • 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.

    PubMed 10915096

  • 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.

    PubMed 11268267

  • 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.

    PubMed 11896345

  • 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.

    PubMed 11399822

  • 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.

    PubMed 12076293

  • 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.

    PubMed 12662277

  • 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.

    PubMed 12519437

  • 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.

    PubMed 12089671

  • 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.

    PubMed 11579276

  • 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.

    PubMed 11493735

  • 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.

    PubMed 11435293

  • 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.

    PubMed 11434728

  • 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.

    PubMed 11343218

Questions about this trial

What is this clinical trial studying?

A study testing blood transfusion in people with Acquired Immunodeficiency Syndrome and Blood Transfusion, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000593, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016; AzTrials last refreshed its copy on 3 Nov 2026.

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