Acquired Immunodeficiency SyndromeNCT00005303
Effectiveness of AIDS Antibody Screening
An observational study of Acquired Immunodeficiency Syndrome and Blood Transfusion, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV) from whole blood and blood components in the blood supply. Read more about this study
- Who is it for?
- Ages 0 years and older, men only
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, Blood Transfusion, HIV Infections
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1986to Sep 1995
- Phase
- Observational
- 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 0 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV) from whole blood and blood components in the blood supply.
Read the detailed description
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1986
- Study completionSep 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Girish Vyas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005303
- Sponsor's protocol ID
- 3004
- Status last verified
- Dec 2001
- First submitted
- 25 May 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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. doi: 10.1002/jmv.1890250102.
PubMed 3411308Hwang 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. doi: 10.1046/j.1537-2995.1989.29289146827.x.
PubMed 2919421Scillian 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.
PubMed 2540862Roy 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 (1988). 1990;3(2):134-8.
PubMed 1967308Cohen ND, Munoz 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. doi: 10.1056/NEJM198905043201803.
PubMed 2710190Yang 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. doi: 10.1002/cyto.990210212.
PubMed 8582240Yang 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. doi: 10.1128/cdli.1.1.26-31.1994.
PubMed 7496917Babu 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. doi: 10.1101/gr.3.1.63. No abstract available.
PubMed 8220187Yang 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.
PubMed 8427989Busch 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. doi: 10.1056/NEJM199107043250101.
PubMed 2046708Donahue JG, Munoz 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. doi: 10.1056/NEJM199208063270601.
PubMed 1320736Nelson KE, Donahue JG, Munoz 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. doi: 10.7326/0003-4819-117-7-554.
PubMed 1524329Donahue JG, Nelson KE, Munoz 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. doi: 10.1093/oxfordjournals.aje.a116023.
PubMed 1720924
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of AIDS Antibody Screening
- ClinicalTrials.gov ID
- NCT00005303
- Acronym / sponsor ID
- 3004
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1986
- Study completion
- Sep 1995
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV) from whole blood and blood components in the blood supply.
Detailed description
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
Study design
- Observational model
- Natural history
Who may qualify
- Ages
- 0 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 3411308Ulrich 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. doi: 10.1002/jmv.1890250102.
- Background: PubMed 2919421Hwang 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. doi: 10.1046/j.1537-2995.1989.29289146827.x.
- Background: PubMed 2540862Scillian 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.
- Background: PubMed 1967308Roy 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 (1988). 1990;3(2):134-8.
- Background: PubMed 2710190Cohen ND, Munoz 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. doi: 10.1056/NEJM198905043201803.
- Background: PubMed 8582240Yang 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. doi: 10.1002/cyto.990210212.
- Background: PubMed 7496917Yang 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. doi: 10.1128/cdli.1.1.26-31.1994.
- Background: PubMed 8220187Babu 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. doi: 10.1101/gr.3.1.63. No abstract available.
- Background: PubMed 8427989Yang 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.
- Background: PubMed 2046708Busch 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. doi: 10.1056/NEJM199107043250101.
- Background: PubMed 1320736Donahue JG, Munoz 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. doi: 10.1056/NEJM199208063270601.
- Background: PubMed 1524329Nelson KE, Donahue JG, Munoz 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. doi: 10.7326/0003-4819-117-7-554.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Girish Vyas
Questions about this trial
What is this clinical trial studying?
An observational study of 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 24 Jun 2005. 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 NCT00005303, which also lists 13 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 24 Jun 2005.