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Ensayos clínicos

Ensayos clínicos

Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00865826, ACTG A5253
  • Concluido

Propósito del estudio

An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with TB, the leading opportunistic infection associated with HIV infection. The purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.

Afección:
Infecciones por el VIH
Tuberculosis

Detalles del estudio

Well developed TB diagnostic testing, contact tracing, and treatment programs are key parts

of the public health and health care infrastructure in many countries where HIV infection

has resulted in a 3- to 10-fold increase in clinical TB, accompanied by increasing HIV

prevalence. The primary purpose of this study is to construct a standardized diagnostic

evaluation (SDE) for TB that provides an increase in identification of participants with

active pulmonary TB, without sacrificing specificity.



This observational study will include participants who are HIV-infected and TB-uninfected

and not receiving ARV therapy. The duration of this trial will last between 1 and 14 days.

Screening and study entry may occur at the same visit. All evaluations must be performed

within 14 days after the participant is registered. Medical and medication history, physical

exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation

of PPD/TST (if available) will occur within this 14-day period.Well developed TB diagnostic testing, contact tracing, and treatment programs are key parts

of the public health and health care infrastructure in many countries where HIV infection

has resulted in a 3- to 10-fold increase in clinical TB, accompanied by increasing HIV

prevalence. The primary purpose of this study is to construct a standardized diagnostic

evaluation (SDE) for TB that provides an increase in identification of participants with

active pulmonary TB, without sacrificing specificity.



This observational study will include participants who are HIV-infected and TB-uninfected

and not receiving ARV therapy. The duration of this trial will last between 1 and 14 days.

Screening and study entry may occur at the same visit. All evaluations must be performed

within 14 days after the participant is registered. Medical and medication history, physical

exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation

of PPD/TST (if available) will occur within this 14-day period.

Criterios de inclusión

    :
    • HIV-infected

Criterios de exclusión

    :
    • Receipt of ART within 90 days prior to study entry
    • Diagnosis of active TB (pulmonary or extrapulmonary) within 90 days prior to study
    entry
    • Receipt of 7 or more cumulative days of certain medications within 90 days prior to
    study entry. More information on this criterion can be found in the protocol.

Centros de estudio/contactos

Botswana

    Gaborone Prevention/Treatment Trials CRS, Gaborone, Botswana

    Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS), Molepolole, Botswana

Rio de Janeiro

    Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Manguinhos, Rio de Janeiro, Brazil

Maharashtra

    BJ Medical College CRS, Pune, Maharashtra, 411001, India

    NARI Pune CRS, Pune, Maharashtra, 411026, India

    University of North Carolina Lilongwe CRS, Lilongwe, Maharashtra, 411026, Malawi

18

    Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS, Lima, 18, 411026, Peru

Lima

    San Miguel CRS, San Miguel, Lima, 411026, Peru

Gauteng

    Soweto ACTG CRS, Johannesburg, Gauteng, 1864, South Africa

    Wits HIV CRS, Johannesburg, Gauteng, 1864, South Africa

KwaZulu-Natal

    Durban Adult HIV CRS, Durban, KwaZulu-Natal, 1864, South Africa

    CAPRISA eThekwini CRS, Durban, KwaZulu-Natal, 4011, South Africa

    UZ-Parirenyatwa CRS (30313), Harare, KwaZulu-Natal, 4011, Zimbabwe

Actualizado: 31 de marzo del 2010

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