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Home > "D" Clinical Trials Conditions > Diagnosing Tuberculosis in HIV Infected Children in Peru  Diagnosing Tuberculosis in HIV Infected Children in Peru
Diagnosing Tuberculosis in HIV Infected Children in Peru
For Condition: HIV Infections,Tuberculosis,Tuberculosis, Pulmonary
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Screening, Cross-Sectional, Case Control, Prospective Study
Minimum Age/Maximum Age: /12 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 520
Location and Contact Information:
Overall Study Official:
RichardOberhelman, Principal Investigator, Tulane School of Public Health and Tropical Medicine
Instituto de Salud del Nino *Recruiting*
Lima, ,
Peru
Recruiting Maria Castillo 011-511-424-1996
Additional Information:
Study ID Numbers: 1R01AI49139-01A1;
Study Start Date: March 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054769
Other Tuberculosis Studies:
1. HIV Expression in Patients with Low Viral Load on Highly Active Antiretroviral Therapy (HAART)
2. Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine
3. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
4. Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
5. A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
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Diagnosing Tuberculosis in HIV Infected Children in Peru
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