Project: Research project

Project Details


The long term objective of this application is to develop a practical,
sensitive and specific approach for the diagnosis of HIV infection in
neonates, infants and children. At the present time there is no reliable
method for diagnosing HIV infection in early life. HIV serology, which is
so useful in adults, is of little value in neonates and infants because of
passively transferred maternal antibodies, which may persist up to and
sometimes beyond 15 months of age. This proposal is based on the premise
that a useful diagnostic approach for this age group can best be developed
by evaluating a battery of tests ('multi-test' approach) done concurrently
in a large enough sample size which would allow statistically valid
comparisons. In our test battery we have included three of what we
consider the most promising tests (in-vitro antibody synthesis, serum
clonotypic analysis and polymerase chain reaction), as well as tests of
restricted value (HIV antigen and antibody) and have coupled these with
immunologic analyses. HIV cultures will be done to confirm a positive
test or to evaluate an ambiguous result. The rationale behind the multi-
test approach is that it would allow us to determine which single test or
which particular combination of tests would be most useful for diagnosing
HIV infection at specified ages after birth. A cohort of 300 seropositive
infants classified as P-O will be enrolled over a 3 year period and each
infant will be longitudinally evaluated clinically as well as by the
multi-test battery at specified time points for a period of 2 years. The
study population will be derived from two inner city hospitals (Brooklyn
and Harlem) and from a suburban hospital in Nassau County. Establishing
reliable methodology for early diagnosis of HIV infection would fulfill an
existing void and facilitate the conduct of clinical trials of anti-HIV
therapies in infants and children.
Effective start/end date12/1/896/30/96


  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health


  • Medicine(all)


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