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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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 Type: Observational
• Enrollment (Actual): 641

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21045
    • Instituto de Pesquisa Clinica Evandro Chagas (12101)
• Peru
  • Lima, Peru, 18 PE
    • Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Wits HIV CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected individuals with suspected TB co-infection

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; HIV-infected individuals with suspected TB co-infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AIDS Clinical Trials Group
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Cynthia (Cindy) Firnhaber, MD, University of Witwatersrand, South Africa

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (ESTIMATE): August 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 11, 2013
• Last Update Submitted That Met QC Criteria: April 9, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ACTG A5255; FASTER; 1U01AI068636 (U.S. NIH Grant/Contract)