IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People (FASTER)
This study has been completed.
Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
Secondary Outcome Measures:
- 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
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 (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959088
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
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Study Chair: | Annie Luetkemeyer, MD | San Francisco General Hospital |
| Study Chair: | Cynthia (Cindy) Firnhaber, MD | University of Witwatersrand, South Africa |
More Information
| 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 |
| Study First Received: | August 12, 2009 |
| Last Updated: | April 9, 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 |
ClinicalTrials.gov processed this record on July 25, 2017