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Diagnosing Tuberculosis in HIV Infected Children in Peru

This study has been completed.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: February 10, 2003
Last updated: September 16, 2008
Last verified: July 2007
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.

Tuberculosis Tuberculosis, Pulmonary HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Diagnostics For AIDS-Related Pediatric TB, Peru

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 760
Study Start Date: March 2002
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Inability to produce sputum sample
  • Clinical picture suggestive of pulmonary TB, score > 7 according to the Stegen and Toledo criteria as adapted by WHO

Exclusion Criteria

  • Antituberculous therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00054769

Instituto de Salud del Nino
Lima, Peru
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Richard A. Oberhelman, MD Tulane School of Public Health and Tropical Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00054769     History of Changes
Other Study ID Numbers: 1R01AI049139-01A1 ( U.S. NIH Grant/Contract )
Study First Received: February 10, 2003
Last Updated: September 16, 2008

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Polymerase Chain Reaction

Additional relevant MeSH terms:
HIV Infections
Tuberculosis, Pulmonary
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on September 21, 2017