HIV Infections Clinical Trial
To define the incidence and prevalence of AIDS-associated cardiomyopathy. Also, to conduct immunopathology and serologic studies in endomyocardial biopsies and autopsy tissues.
BACKGROUND:
In 1988, the leading cause of death in AIDS patients was respiratory mechanisms might have
played a significant role in its pathogenesis.
The project was part of an Institute-initiated study on AIDS-Associated Heart Disease in
Adults. The concept was approved by the National Heart, Lung, and Blood Advisory Council in
September 1987. The Request for Applications was also released in September 1987. Awards
were made in July 1988.
DESIGN NARRATIVE:
The prevalence study was one of three subprojects with the common failure due to chronic
opportunistic pulmonary infection, primarily Pneumocystis carinii pneumonia. Drugs such as
azidothymidine (AZT) and trimetrexate showed some effectiveness in prolonging the lives of
some AIDS patients. With increased survival, it was believed that cardiac diseases might
well become an important complication of AIDs. Reports described a syndrome of rapidly
progressive cardiomyopathy associated with AIDS. The etiology of AIDS-associated
cardiomyopathy was yet unknown although immunologic theme of the immunopathogenesis of
AIDS-associated cardiomyopathy. The other two subprojects dealt with immunopathology studies
in endomyocardial biopsies and autopsy tissues and serologic studies. The AIDS Clinical
Research Center at Johns Hopkins Hospital served as the source of patients. All patients
underwent serologic testing and echocardiography at time of entry and at six and twelve
months. The screening electrocardiogram identified 40 to 50 patients per year with
AIDS-associated cardiomyopathy. Approximately 30 patients per year had no contraindications
for endomyocardial biopsy. Comprehensive tissue studies and cellular immune studies were
performed on the cohort and autopsies, if possible. Immunohistochemical techniques and in
situ hybridization of biopsy and autopsy material were used to determine if AIDS-associated
cardiomyopathy was associated with HIV infection of the heart or with some other viral or
opportunistic non-viral infection. Indirect immunofluorescence and a Western immunoblotting
assay using patient sera determined the prevalence of heart autoimmunity.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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