HIV Infections Clinical Trial
Official title:
Diagnostics For AIDS-Related Pediatric TB, Peru
Tuberculosis is a major cause of mortality among AIDS patients in the developing world. The diagnosis of tuberculosis in HIV infected children is complicated by inefficient and expensive tuberculosis tests and vague diagnostic criteria. This study will evaluate the accuracy and efficiency of several different tuberculosis tests that could be used in developing countries.
HIV infection has been shown to increase mortality from tuberculosis (TB) fivefold in parts
of Subsaharan Africa. Increasingly, HIV infected children in developing countries are
becoming infected with Mycobacterium tuberculosis (Mtb) and dying at an early age. This
project will evaluate novel approaches to the diagnosis of AIDS-related pediatric TB in a
hyperendemic setting using rapid, cost-effective Mtb culture and susceptibility methods
based on direct microscopic observation techniques. This study will utilize alternative
noninvasive Mtb tests that are performed on nasopharyngeal aspirates (NPA) and stool. An
optional component will assess improved rapid detection of Mtb by a semi-nested polymerase
chain reaction assay (N2 PCR), a technique appropriate for regional reference laboratories
in developing countries.
Two hundred-sixty children with clinically diagnosed pulmonary TB (including at least 100
HIV infected children) from the Hospital del Nino, Lima, Peru, and 260 age-matched controls
will be enrolled in this study. Mtb will be detected in NPAs and stool by new and
traditional culture methods and by N2 PCR. Gastric aspirates from children with a clinical
diagnosis of TB will also be tested. Children with a positive N2 PCR but without clinical
evidence of TB requiring antituberculous therapy will be followed longitudinally.
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Time Perspective: Prospective
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