Early identification of tuberculosis (TB) is of particular importance in HIV-infected individuals, as a delay of therapy can be devastating in those with compromised immune systems. Diagnosis of TB in HIV is difficult, however, because 24-61% of HIV co-infected individuals with pulmonary TB have negative TB test results. In addition, conventional testing can take 6 weeks or longer and may not be available at all in many settings. This study is being conducted to see whether some new tests for identifying TB and for identifying resistance to TB drugs are at least as accurate as the current testing methods when used on HIV-infected individuals. The study will also assess whether the new tests can provide accurate results faster than the current methods.
Early diagnosis of tuberculosis (TB) is of particular importance in HIV-infected individuals, as a delay of therapy can be devastating in those with compromised immune systems. Diagnosis of TB in HIV can be a particular challenge, however, because 24-61% of HIV co-infected individuals with pulmonary TB are smear-negative. Conventional solid media-based culture can take 6 weeks or longer for mycobacterial growth, and may not be available at all in many settings. The purpose of this study is to determine whether new tests for identifying TB and resistance to TB drugs are as effective as current tests and if these new tests can provide accurate results faster than the current method of testing for TB and drug resistance. This trial will enroll HIV-infected individuals who are suspected to be co-infected with TB. Participants may be in this trial for up to nine months, depending on their test results. During the study, participants will provide one or two sputum samples, have a chest x-ray, and may have blood collected.
Study Type
OBSERVATIONAL
Enrollment
641
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, Brazil
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
Lima, Peru
Wits HIV CRS
Johannesburg, Gauteng, South Africa
GenoType Direct line probe assay result (MTB-positive or negative) and conventional mycobacterial culture assay result (MTB-positive or negative) on direct sputum samples
Time frame: Throughout study
GenoType Direct line probe assay results on direct sputum samples
Time frame: Throughout study
GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples
Time frame: Throughout study
Identified strains of drug resistant MTB
Time frame: Throughout study
AFB smear with ZN staining results
Time frame: Throughout study
AFB smear as evaluated with fluorescent microscopy results
Time frame: Throughout study
MTB culture results (including speciation and, if indicated, drug susceptibility)
Time frame: Throughout study
MTB blood culture results
Time frame: Throughout study
Follow up clinical assessment of MTB disease status
Time frame: Throughout study
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