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

Sponsor
AIDS Clinical Trials Group (Other)
Overall Status
Completed
CT.gov ID
NCT00959088
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
641
Enrollment
3
Locations
34
Duration (Months)
213.7
Patients Per Site
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    641 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment
    Study Start Date :
    Aug 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    1

    HIV-infected individuals with suspected TB co-infection.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. GenoType Direct line probe assay results on direct sputum samples [Throughout study]

    2. GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples [Throughout study]

    3. Identified strains of drug resistant MTB [Throughout study]

    4. AFB smear with ZN staining results [Throughout study]

    5. AFB smear as evaluated with fluorescent microscopy results [Throughout study]

    6. MTB culture results (including speciation and, if indicated, drug susceptibility) [Throughout study]

    7. MTB blood culture results [Throughout study]

    8. Follow up clinical assessment of MTB disease status [Throughout study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto de Pesquisa Clinica Evandro Chagas (12101) Rio de Janeiro Brazil 21045
    2 Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301) Lima Peru 18 PE
    3 Wits HIV CRS Johannesburg Gauteng South Africa

    Sponsors and Collaborators

    • AIDS Clinical Trials Group
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: Annie Luetkemeyer, MD, San Francisco General Hospital
    • Study Chair: Cynthia (Cindy) Firnhaber, MD, University of Witwatersrand, South Africa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AIDS Clinical Trials Group
    ClinicalTrials.gov Identifier:
    NCT00959088
    Other Study ID Numbers:
    • ACTG A5255
    • 1U01AI068636
    • FASTER
    First Posted:
    Aug 14, 2009
    Last Update Posted:
    Apr 11, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Apr 11, 2013