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
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

samples of sputum and blood may be retained


Enrollment: 641
Study Start Date: August 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HIV-infected individuals with suspected TB co-infection.

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected individuals with suspected TB co-infection

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959088

Locations
Brazil
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, Brazil, 21045
Peru
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
Lima, Peru, 18 PE
South Africa
Wits HIV CRS
Johannesburg, Gauteng, South Africa
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Annie Luetkemeyer, MD San Francisco General Hospital
Study Chair: Cynthia (Cindy) Firnhaber, MD University of Witwatersrand, South Africa
  More Information

No publications provided

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00959088     History of Changes
Other Study ID Numbers: ACTG A5255, 1U01AI068636, FASTER
Study First Received: August 12, 2009
Last Updated: April 9, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014