HIV InfectionsFASTERNCT00959088
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 641 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-infected individuals with suspected TB co-infection
Who may be able to join
- 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.
Who cannot join
- Receipt of 7 or more cumulative days of anti-TB treatment within 12 months prior to sputum collection
- Inability to provide sputum sample
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, 21045
Peru1 site
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
Lima, 18 PE
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV-infected individuals with suspected TB co-infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GenoType Direct line probe assay result (MTB-positive or negative) and conventional mycobacterial culture assay result (MTB-positive or negative) on direct sputum samples
Measured: Throughout study
Secondary outcomes (8)
GenoType Direct line probe assay results on direct sputum samples
Measured: Throughout study
GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples
Measured: Throughout study
Identified strains of drug resistant MTB
Measured: Throughout study
AFB smear with ZN staining results
Measured: Throughout study
AFB smear as evaluated with fluorescent microscopy results
Measured: Throughout study
MTB culture results (including speciation and, if indicated, drug susceptibility)
Measured: Throughout study
MTB blood culture results
Measured: Throughout study
Follow up clinical assessment of MTB disease status
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Annie Luetkemeyer, MD, Study chair, San Francisco General HospitalCynthia (Cindy) Firnhaber, MD, Study chair, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959088
- Sponsor's protocol ID
- ACTG A5255
- Other IDs
- 1U01AI068636, FASTER
- Acronym
- FASTER
- Status last verified
- Apr 2013
- First submitted
- 12 Aug 2009
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment
- ClinicalTrials.gov ID
- NCT00959088
- Acronym / sponsor ID
- FASTER / ACTG A5255
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Aug 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HIV-infected individuals with suspected TB co-infection. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-infected individuals with suspected TB co-infection
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Receipt of 7 or more cumulative days of anti-TB treatment within 12 months prior to sputum collection
- Inability to provide sputum sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie Luetkemeyer, MD study chair
San Francisco General Hospital
Cynthia (Cindy) Firnhaber, MD study chair
University of Witwatersrand, South Africa
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Peru, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.