HIV Infections Clinical Trial
To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV) from whole blood and blood components in the blood supply.
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.
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