Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People (FASTER)
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ClinicalTrials.gov Identifier: NCT00959088 |
Recruitment Status
:
Completed
First Posted
: August 14, 2009
Last Update Posted
: April 11, 2013
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Condition or disease |
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HIV Infections |
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 |
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 : | August 2009 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Group/Cohort |
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1
HIV-infected individuals with suspected TB co-infection.
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- 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 ]
- GenoType Direct line probe assay results on direct sputum samples [ Time Frame: Throughout study ]
- GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples [ Time Frame: Throughout study ]
- Identified strains of drug resistant MTB [ Time Frame: Throughout study ]
- AFB smear with ZN staining results [ Time Frame: Throughout study ]
- AFB smear as evaluated with fluorescent microscopy results [ Time Frame: Throughout study ]
- MTB culture results (including speciation and, if indicated, drug susceptibility) [ Time Frame: Throughout study ]
- MTB blood culture results [ Time Frame: Throughout study ]
- Follow up clinical assessment of MTB disease status [ Time Frame: Throughout study ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959088
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 |
Study Chair: | Annie Luetkemeyer, MD | San Francisco General Hospital | |
Study Chair: | Cynthia (Cindy) Firnhaber, MD | University of Witwatersrand, South Africa |
Responsible Party: | AIDS Clinical Trials Group |
ClinicalTrials.gov Identifier: | NCT00959088 History of Changes |
Other Study ID Numbers: |
ACTG A5255 1U01AI068636 ( U.S. NIH Grant/Contract ) FASTER |
First Posted: | August 14, 2009 Key Record Dates |
Last Update Posted: | April 11, 2013 |
Last Verified: | April 2013 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |