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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00959088
First received: August 12, 2009
Last updated: April 9, 2013
Last verified: April 2013

August 12, 2009
April 9, 2013
August 2009
June 2012   (final data collection date for primary outcome 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959088 on ClinicalTrials.gov Archive Site
  • GenoType Direct line probe assay results on direct sputum samples [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Identified strains of drug resistant MTB [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AFB smear with ZN staining results [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AFB smear as evaluated with fluorescent microscopy results [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • MTB culture results (including speciation and, if indicated, drug susceptibility) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • MTB blood culture results [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Follow up clinical assessment of MTB disease status [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People
Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

samples of sputum and blood may be retained

Non-Probability Sample

HIV-infected individuals with suspected TB co-infection

HIV Infections
Not Provided
1
HIV-infected individuals with suspected TB co-infection.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
641
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Peru,   South Africa
 
NCT00959088
ACTG A5255, 1U01AI068636, FASTER
Yes
AIDS Clinical Trials Group
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Annie Luetkemeyer, MD San Francisco General Hospital
Study Chair: Cynthia (Cindy) Firnhaber, MD University of Witwatersrand, South Africa
AIDS Clinical Trials Group
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP