HIV InfectionsNCT00865826
Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
An observational study of HIV Infections and Tuberculosis, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 13 sites in 7 countries.
Trial summary
An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Standardized diagnostic evaluation
- How many people
- 801 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Dec 2009to Mar 2011
- 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 males and females who are not currently receiving ART
Who may be able to join
- HIV-infected
Who cannot join
- Receipt of ART within 90 days prior to study entry
- Diagnosis of active TB (pulmonary or extrapulmonary) within 90 days prior to study entry
- Receipt of 7 or more cumulative days of certain medications within 90 days prior to study entry. More information on this criterion can be found in the protocol.
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
South Africa4 sites
CAPRISA eThekwini CRS
Durban, KwaZulu-Natal, 4011
Durban Adult HIV CRS
Durban, KwaZulu-Natal
Soweto ACTG CRS
Johannesburg, Gauteng, 1864
Wits HIV CRS
Johannesburg, Gauteng
Botswana2 sites
Gaborone Prevention/Treatment Trials CRS
Gaborone
Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS)
Molepolole
India2 sites
BJ Medical College CRS
Pune, Maharashtra, 411001
NARI Pune CRS
Pune, Maharashtra, 411026
Peru2 sites
Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS
Lima, 18
San Miguel CRS
San Miguel, Lima region
Brazil1 site
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Manguinhos, Rio de Janeiro
About this study
Official title: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with TB, the leading opportunistic infection associated with HIV infection. The purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.
Read the detailed description
Well developed TB diagnostic testing, contact tracing, and treatment programs are key parts of the public health and health care infrastructure in many countries where HIV infection has resulted in a 3- to 10-fold increase in clinical TB, accompanied by increasing HIV prevalence. The primary purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.
This observational study will include participants who are HIV-infected and TB-uninfected and not receiving ARV therapy. The duration of this trial will last between 1 and 14 days. Screening and study entry may occur at the same visit. All evaluations must be performed within 14 days after the participant is registered. Medical and medication history, physical exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation of PPD/TST (if available) will occur within this 14-day period.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Standardized diagnostic evaluation
- Keywords
- Pulmonary Tuberculosis, Myobacterium Infections
- Medical subject headings
- HIV Infections, Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized diagnostic evaluationOther
Also called SDE
Participants will undergo a diagnostic evaluation for TB at study entry
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV-infected males and females who are not currently receiving ART Receives: Other: Standardized diagnostic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB
Measured: Throughout study
Secondary outcomes (6)
Prevalence of TB in symptomatic and asymptomatic individuals
Measured: Throughout study
Rates of TB drug resistance
Measured: Throughout study
Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts
Measured: Throughout study
Value of oral candidiasis as a predictor of TB
Measured: Throughout study
Significance of investigational serologic assay when added to sputum acid-fast bacilli (AFB) smears when identifying participants with active TB compared to AFB smears alone
Measured: Throughout study
Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors
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 posted19 Mar 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Susan Swindells, MBBS, Study chair, University of NebraskaSrikanth Tripathy, MBBS, Study chair, National AIDS Research Institute, MIDC, Bhosari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865826
- Sponsor's protocol ID
- ACTG A5253
- Other IDs
- 1U01AI068636
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2009
- Last updated
- 18 Mar 2015
- Results posted
- No
Publications
Aichelburg MC, Rieger A, Breitenecker F, Pfistershammer K, Tittes J, Eltz S, Aichelburg AC, Stingl G, Makristathis A, Kohrgruber N. Detection and prediction of active tuberculosis disease by a whole-blood interferon-gamma release assay in HIV-1-infected individuals. Clin Infect Dis. 2009 Apr 1;48(7):954-62. doi: 10.1086/597351.
PubMed 19245343Ani AE. Advances in the laboratory diagnosis of Mycobacterium tuberculosis. Ann Afr Med. 2008 Jun;7(2):57-61. doi: 10.4103/1596-3519.55680.
PubMed 19143160
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
- ClinicalTrials.gov ID
- NCT00865826
- Acronym / sponsor ID
- ACTG A5253
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Pulmonary Tuberculosis, Myobacterium Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Mar 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.
An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with TB, the leading opportunistic infection associated with HIV infection. The purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.
Detailed description
Well developed TB diagnostic testing, contact tracing, and treatment programs are key parts of the public health and health care infrastructure in many countries where HIV infection has resulted in a 3- to 10-fold increase in clinical TB, accompanied by increasing HIV prevalence. The primary purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.
This observational study will include participants who are HIV-infected and TB-uninfected and not receiving ARV therapy. The duration of this trial will last between 1 and 14 days. Screening and study entry may occur at the same visit. All evaluations must be performed within 14 days after the participant is registered. Medical and medication history, physical exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation of PPD/TST (if available) will occur within this 14-day period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Standardized diagnostic evaluationHIV-infected males and females who are not currently receiving ART |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-infected males and females who are not currently receiving ART
Key inclusion criteria (1 listed)
- HIV-infected
Key exclusion criteria (3 listed)
- Receipt of ART within 90 days prior to study entry
- Diagnosis of active TB (pulmonary or extrapulmonary) within 90 days prior to study entry
- Receipt of 7 or more cumulative days of certain medications within 90 days prior to study entry. More information on this criterion can be found in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized diagnostic evaluationAlso: SDEParticipants will undergo a diagnostic evaluation for TB at study entry | Other | 1 |
Primary outcome
Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB
Time frame: Throughout study
6 secondary outcomes
Prevalence of TB in symptomatic and asymptomatic individuals
Time frame: Throughout study
Rates of TB drug resistance
Time frame: Throughout study
Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts
Time frame: Throughout study
Value of oral candidiasis as a predictor of TB
Time frame: Throughout study
Significance of investigational serologic assay when added to sputum acid-fast bacilli (AFB) smears when identifying participants with active TB compared to AFB smears alone
Time frame: Throughout study
Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors
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 18 Mar 2015.
- Background: PubMed 19245343Aichelburg MC, Rieger A, Breitenecker F, Pfistershammer K, Tittes J, Eltz S, Aichelburg AC, Stingl G, Makristathis A, Kohrgruber N. Detection and prediction of active tuberculosis disease by a whole-blood interferon-gamma release assay in HIV-1-infected individuals. Clin Infect Dis. 2009 Apr 1;48(7):954-62. doi: 10.1086/597351.
- Background: PubMed 19143160Ani AE. Advances in the laboratory diagnosis of Mycobacterium tuberculosis. Ann Afr Med. 2008 Jun;7(2):57-61. doi: 10.4103/1596-3519.55680.
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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.
Susan Swindells, MBBS study chair
University of Nebraska
Srikanth Tripathy, MBBS study chair
National AIDS Research Institute, MIDC, Bhosari
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Tuberculosis, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 13 sites in 7 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 1 inclusion and 3 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Africa, Botswana, India, Peru, Brazil and 2 more countries. 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?
Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00865826, which also lists 2 linked publications.
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 18 Mar 2015.