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Ensayos clínicos

Ensayos clínicos

Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00959088, ACTG A5255
  • En curso, con inscripciones cerradas

Propósito del estudio

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.

Afección:
Infecciones por el VIH

Detalles del estudio

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.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.

Criterios de inclusión

    :
    • HIV-1 infection, as documented at any time prior to study entry by a rapid HIV test
    or any licensed ELISA test kit
    • Probable or confirmed pulmonary TB at the time of enrollment
    • Current use of an anti-TB regimen for treatment of active TB for fewer than 7 days
    prior to sputum sample collection or anticipated initiation of same within 30 days after study entry
    • Ability and willingness of participant or legal guardian/representative to provide
    informed consent.

Criterios de exclusión

    • Receipt of 7 or more cumulative days of anti-TB treatment within 12 months prior to
    sputum collection
    • Inability to provide sputum sample

Centros de estudio/contactos

Brazil

    Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro, 21045, Brazil

Peru

    Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima, 18 PE, Peru

Gauteng

    Wits HIV CRS, Johannesburg, Gauteng, 18 PE, South Africa

Actualizado: 8 de enero del 2010

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