Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People (FASTER)
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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 |
- 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 ]
- 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 |
HIV-infected individuals with suspected TB co-infection
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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:
|
Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 25, 2015