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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria Receipt of 7 or more cumulative days of anti-TB treatment within 12 months prior to sputum collection Inability to provide sputum sample

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 individuals with suspected TB co-infection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GenoType Direct line probe assay result (MTB-positive or negative) and conventional mycobacterial culture assay result (MTB-positive or negative) on direct sputum samples |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GenoType Direct line probe assay results on direct sputum samples |  | Throughout study | 
| GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples |  | Throughout study | 
| Identified strains of drug resistant MTB |  | Throughout study | 
| AFB smear with ZN staining results |  | Throughout study | 
| AFB smear as evaluated with fluorescent microscopy results |  | Throughout study | 
| MTB culture results (including speciation and, if indicated, drug susceptibility) |  | Throughout study | 
| MTB blood culture results |  | Throughout study | 
| Follow up clinical assessment of MTB disease status |  | Throughout study |