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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

Conditions
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HIV Infections, Tuberculosis

Intervention / Treatment
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* Other: Standardized diagnostic evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>HIV-infected males and females who are not currently receiving ART | Other: Standardized diagnostic evaluation<br>* Participants will undergo a diagnostic evaluation for TB at study entry<br>* Other names: SDE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of TB in symptomatic and asymptomatic individuals |  | Throughout study | 
| Rates of TB drug resistance |  | Throughout study | 
| Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts |  | Throughout study | 
| Value of oral candidiasis as a predictor of TB |  | Throughout study | 
| Significance of investigational serologic assay when added to sputum acid-fast bacilli (AFB) smears when identifying participants with active TB compared to AFB smears alone |  | Throughout study | 
| Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Tuberculosis, Myobacterium Infections