Clinical trial NCT00959088: Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People
Official title: Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-08-14
Enrollment: 641
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected individuals with suspected TB co-infection

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: GenoType Direct line probe assay result (MTB-positive or negative) and conventional mycobacterial culture assay result (MTB-positive or negative) on direct sputum samples
timeFrame: Throughout study
Secondary outcomes:
measure: GenoType Direct line probe assay results on direct sputum samples
timeFrame: Throughout study
measure: GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples
timeFrame: Throughout study
measure: Identified strains of drug resistant MTB
timeFrame: Throughout study
measure: AFB smear with ZN staining results
timeFrame: Throughout study
measure: AFB smear as evaluated with fluorescent microscopy results
timeFrame: Throughout study
measure: MTB culture results (including speciation and, if indicated, drug susceptibility)
timeFrame: Throughout study
measure: MTB blood culture results
timeFrame: Throughout study
measure: Follow up clinical assessment of MTB disease status
timeFrame: Throughout study
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto de Pesquisa Clinica Evandro Chagas (12101)
city: Lima
country: Peru
facility: Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
city: Johannesburg
country: South Africa
facility: Wits HIV CRS
state: Gauteng
Study officials:
affiliation: San Francisco General Hospital
name: Annie Luetkemeyer, MD
role: STUDY_CHAIR
affiliation: University of Witwatersrand, South Africa
name: Cynthia (Cindy) Firnhaber, MD
role: STUDY_CHAIR
References: