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

HIV Infections Clinical Trial

— FASTER  

Official title:

Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959088
• Other study ID #: ACTG A5255
• Secondary ID: 1U01AI068636FAST
• Status: Completed
• Phase: N/A
• First received: August 12, 2009
• Last updated: April 9, 2013
• Start date: August 2009
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Brazil	Instituto de Pesquisa Clinica Evandro Chagas (12101)	Rio de Janeiro
Peru	Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)	Lima
South Africa	Wits HIV CRS	Johannesburg	Gauteng

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Clinical Trials Group	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

Brazil,  Peru,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	GenoType Direct line probe assay results on direct sputum samples		Throughout study	No
Secondary	GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples		Throughout study	No
Secondary	Identified strains of drug resistant MTB		Throughout study	No
Secondary	AFB smear with ZN staining results		Throughout study	No
Secondary	AFB smear as evaluated with fluorescent microscopy results		Throughout study	No
Secondary	MTB culture results (including speciation and, if indicated, drug susceptibility)		Throughout study	No
Secondary	MTB blood culture results		Throughout study	No
Secondary	Follow up clinical assessment of MTB disease status		Throughout study	No