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Effectiveness of AIDS Antibody Screening

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 26, 2000
Last Update Posted: December 9, 2005
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)
To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV) from whole blood and blood components in the blood supply.

Acquired Immunodeficiency Syndrome Blood Transfusion HIV Infections

Study Type: Observational
Study Design: Observational Model: Natural History

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1986
Estimated Study Completion Date: September 1995
Detailed Description:


In 1986, despite programs to have persons with known risk factors for exposure to the AIDS virus exclude themselves from the blood donating population and the universal testing of all donated whole blood and blood components for the antibody to HIV, the public was fearful of acquiring AIDS via transfusion and media stories increased that fear. A major concern among members of the blood banking community was the extent to which donors infected with HIV were not identified by enzyme-linked immunoassay (EIA) systems. Most experts believed that self-deferral and the assays for the HIV antibody were eliminating the vast majority of positive units of donated blood and blood components. If all units containing HIV were being eliminated by the combined effects of self-deferral and antibody screening (and treatment of factor VIII concentrates), no recipients of only screened whole blood or blood components or factor VIII would become HIV virus and antibody positive as the result of transfusion. Alternately, if some HIV positive units of whole blood or blood components or factor VIII concentrates were not being eliminated by self-deferral and antibody screening (and treatment of factor VIII concentrates), and these units were transfused, then some transfusion recipients would become HIV antibody positive and viremic.

The initiative was part of a special Fiscal Year 1986 National Heart, Lung, and Blood Institute AIDS Plan. The concept was reviewed and approved by the National Heart, Lung, and Blood Advisory Council in February 1986. The Request for Proposals was released in May 1986. Two contracts were awarded in September 1986.


University of California at San Francisco: A risk assessment was made of HIV infection through prospective testing for seroconversion in women recipients of anti-HIV negative blood transfusions at the University of California San Francisco hospitals. Blood specimens were collected from each of the recipients pre-transfusion, and at two, four, and six months post-transfusion. Patients were selected based on female sex and exclusion of high risk behavior or blood transfusion during the preceding six months.

Johns Hopkins University: The rate of seroconversion was determined in a cohort of cardiac surgery patients receiving multiple transfusions of blood products screened for HIV antibody. The study was conducted at the Johns Hopkins Hospital, the Texas Heart Institute, and the Methodist Hospital in Houston. A serum sample for each patient was collected before surgery and a second sample was collected at least six months after surgery.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00005303

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Girish Vyas
  More Information

Ulrich PP, Busch MP, el-Beik T, Shiota J, Vennari J, Shriver K, Vyas GN. Assessment of human immunodeficiency virus expression in cocultures of peripheral blood mononuclear cells from healthy seropositive subjects. J Med Virol. 1988 May;25(1):1-10.
Hwang LY, Beasley RP, Busch MP, Lane PK, Vyas GN. Human immunodeficiency virus seroprevalence among blood product recipients in San Francisco before transfusion. Transfusion. 1989 Feb;29(2):113-8.
Scillian JJ, McHugh TM, Busch MP, Tam M, Fulwyler MJ, Chien DY, Vyas GN. Early detection of antibodies against rDNA-produced HIV proteins with a flow cytometric assay. Blood. 1989 May 15;73(7):2041-8.
Roy S, Morrow WJ, Christian C, Khayam-Bashi H, Busch MP, McCarthy R, Rodgers RP, Vyas GN. Persistent immune complexes and abnormal CD4/CD8 ratios in HIV infection. J Acquir Immune Defic Syndr. 1990;3(2):134-8.
Cohen ND, Muñoz A, Reitz BA, Ness PK, Frazier OH, Yawn DH, Lee H, Blattner W, Donahue JG, Nelson KE, et al. Transmission of retroviruses by transfusion of screened blood in patients undergoing cardiac surgery. N Engl J Med. 1989 May 4;320(18):1172-6.
Yang G, Olson JC, Pu R, Vyas GN. Flow cytometric detection of human immunodeficiency virus type 1 proviral DNA by the polymerase chain reaction incorporating digoxigenin- or fluorescein-labeled dUTP. Cytometry. 1995 Oct 1;21(2):197-202.
Yang G, Garhwal S, Olson JC, Vyas GN. Flow cytometric immunodetection of human immunodeficiency virus type 1 proviral DNA by heminested PCR and digoxigenin-labeled probes. Clin Diagn Lab Immunol. 1994 Jan;1(1):26-31.
Babu PG, Rawal BD, Khayam-Bashi H, Vyas GN. Detection of exceedingly low levels of HIV proviral DNA in multimillion peripheral blood mononuclear cells by PCR. PCR Methods Appl. 1993 Aug;3(1):63-4.
Yang G, Ulrich PP, Aiyer RA, Rawal BD, Vyas GN. Detection of hepatitis B virus in plasma using flow cytometric analyses of polymerase chain reaction-amplified DNA incorporating digoxigenin-11-dUTP. Blood. 1993 Feb 15;81(4):1083-8.
Busch MP, Eble BE, Khayam-Bashi H, Heilbron D, Murphy EL, Kwok S, Sninsky J, Perkins HA, Vyas GN. Evaluation of screened blood donations for human immunodeficiency virus type 1 infection by culture and DNA amplification of pooled cells. N Engl J Med. 1991 Jul 4;325(1):1-5.
Donahue JG, Muñoz A, Ness PM, Brown DE Jr, Yawn DH, McAllister HA Jr, Reitz BA, Nelson KE. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med. 1992 Aug 6;327(6):369-73.
Nelson KE, Donahue JG, Muñoz A, Cohen ND, Ness PM, Teague A, Stambolis VA, Yawn DH, Callicott B, McAllister H, et al. Transmission of retroviruses from seronegative donors by transfusion during cardiac surgery. A multicenter study of HIV-1 and HTLV-I/II infections. Ann Intern Med. 1992 Oct 1;117(7):554-9.
Donahue JG, Nelson KE, Muñoz A, Vlahov D, Rennie LL, Taylor EL, Saah AJ, Cohn S, Odaka NJ, Farzadegan H. Antibody to hepatitis C virus among cardiac surgery patients, homosexual men, and intravenous drug users in Baltimore, Maryland. Am J Epidemiol. 1991 Nov 15;134(10):1206-11.

ClinicalTrials.gov Identifier: NCT00005303     History of Changes
Other Study ID Numbers: 3004
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: December 9, 2005
Last Verified: December 2001

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases

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