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Title of study Summary and Purpose Field/research Study type Study design Intervention Study location Sponsor, collaborator and

investigator

Study population/condition Sample size Available source of

information (website, trial

identity code)

Video Directly Observed Therapy

(VDOT) to Monitor Short-Course

LTBI Treatment

A novel mHealth application that allows patients to make

and send videos of each medication dose ingested that are

watched by healthcare providers via a HIPAA-compliant

website to remotely monitor LTBI treatment adherence

(Video DOT [VDOT]) has been developed. This study will

determine whether monitoring patients with VDOT achieves

higher treatment completion rates and greater patient

acceptability at lower cost than clinic-based in-person DOT.

Adherance and completion

in treatment

Interventional Allocation: Randomized

Endpoint Classification: Efficacy

Study

Intervention Model: Parallel

Assignment

Masking: Open Label

Video Directly Observed Therapy,

In-Person DOT (Control)

USA Sponsor:

University of California, San Diego TB contacts and refugees in San

Diego who are prescribed 3HP for

LTBI treatment by their physician

will be randomly assigned to be

monitored for adherence via

either VDOT or in-person DOT

310 NCT02641106

Quantiferon Gold Test for Detecting

TB Infection in HIV/AIDS Patients in

South Africa

To compare the effectiveness of linking the Quantiferon-gold

in-tube test (QGIT) with routine CD4 testing to the routine

use of the tuberculin skin test (TST), the current standard of

care for diagnosing latent tuberculosis infection (LTBI) in

South Africa. The investigators hypothesize that QGIT clinics

will identify LTBI and initiate isoniazid preventive therapy

(IPT) in a higher proportion of patients and in a significantly

faster timeframe. The cost-effectiveness of linking QGIT

with routine CD4 compared to routine TST will also be

evaluated,

Performance of comercially

available immunotests



Assignment

Masking: Open Label

Primary Purpose: Diagnostic

Device: QGIT

South Africa Sponsor:

Johns Hopkins University

Collaborators:

National Institute of Allergy and

Infectious Diseases (NIAID)

University of Witwatersrand, South

Africa

3000 NCT02119130

Vitamin D Suplementation in TB

Prevention

The goal of this clinical trial is to investigate the preventive

role of vitamin D supplementation in school age children in a

high transmission setting. The investigators hypothesis is

that (1) vitamin D supplementation will reduce rate of

acquisition of LTBI, (2) vitamin D supplementation will lead

to greater reductions in active TB incidence, and (3) children

with the lowest vitamin D status at baseline will gain most

Treatment/intervention

Interventional

Phase 3, Allocation: Randomized


Assignment

Masking: Double Blind (Subject,

Caregiver, Investigator,

Outcomes Assessor)

Primary Purpose: Prevention

•Dietary Supplement:

cholecalciferol (vitamin D)

14000 IU vitamin D3 weekly

Experimental group will receive

vitamin D supplement (Tishcon,

USA).

Not provided

Sponsor:

Harvard School of Public Health

Healthy children ages between

6 and 13 years, enrolled in

participating schools

Not currently TB infected.

8200 NCT02276755

Toward a Safe and Reachable

Preventive Therapy for LTBI: a

Multicenter Randomized Controlled

Study in Taiwan

The incidence of TB in Taiwan has gradually declined in

recent 10 years. In order to maintain the trend of decreasing

in incidence, preventive therapy for LTBI become more and

more important. However, which is the best preventive

regimen for LTBI is still unknown. Therefore, we conduct the

prospective randomized multicenter studies to compare the

treatment completion rate of two regimens in Taiwan. The

first regimen is daily isoniazid for 9 months. The second is

weekly rifapentine plus high-dose isoniazid for 3 months.

Treatment/intervention Interventional Phase 3 Allocation: Randomized

Endpoint Classification:

Safety/Efficacy Study


Assignment

Masking: Open Label


Rifapentine and Isoniazid for 3 months

versus Isoniazid for 9 months Taiwan

Sponsor:

National Taiwan University Hospital 322 NCT02208427

Diagnosis of Active and Latent TB

Infection With IFN-y Assays in

African Children

Study based in Southern Ethiopia Purpose - to explore if

children in contact with adults with TB have positive acute

reactants such as IFN-y and other cytokine responses; if

these responses discriminate between high and low risk of

disease progression and whether these could be

incorporated into improved diagnostic approaches.



Observational Observational Model: Defined

Population

Time Perspective: Longitudinal

Not provided Ethiopia Sponsor:

Liverpool School of Tropical Medicine

Collaborator:

Thrasher Research Fund

Children with suspicion of TB

attending health centres will

also be investigated

500

NCT00456469

The Role of Apoptosis Associated

Markers in Pathogenesis of

Pulmonary Tuberculosis

The apoptosis-associated markers, including Fas ligand,

Decoy-receptor 3, Lipoxin, and prostaglandin E2, are

discriminative in patients with active TB from those with LTBI

and thus might predict the potential of being active TB from

LTBI. To compare the serum apoptosis-associated markers

between patients with active TB and patients with LTBI To

evaluate the efficiency of apoptosis-associated markers to

differentiate potential of active TB from LTBI

Development of new tests

with improved performance

and biomarkers

Observational Observational Model: Case

Control

Time Perspective: Prospective

Not provided Taiwan

National Taiwan University Hospital

1.Patients with tuberculosis:

microbiology or pathology

proven tuberculosis infection

2.Patients with latent

tuberculosis infection are

defined by interferon-gamma

release assay

3.Patients without tuberculosis

and latent tuberculosis are

defi=ed by negative findings in

above-mentioned results

400 NCT01676155

Prognostic Value of Interferon

Gamma Release Assays in Predicting

Active Tuberculosis Among

Individuals With, or at Risk of,

Latent Tuberculosis Infection

The objective of this study is to assess the efficacy of the two

current TB (tuberculosis) blood tests (Interferon Gamma

Release Assays (IGRA)) compared with the standard skin test

(Mantoux Tuberculin Skin Test (TST)), for predicting active

tuberculosis among those at increased risk of TB. Those at

increased risk are defined as either newly arrived immigrants

or people who have been in contact with TB cases. The study

will also provide information on the cost effectiveness of

different testing strategies, such as the two step testing

approach recommended by NICE.

Programme management Observational Observational Model: Cohort


Not provided United Kingdom Sponsor:

Public Health England

Collaborators:

Imperial College London

Queen Mary University of London

University College, London

Brunel University

University of Birmingham

Those who are close contacts

of active tuberculosis cases or

those who have are new

entrants to the UK from high

incidence countries

(>40/100000).

10000 NCT01162265

Study to Evaluate the Tolerability

and Immunogenicity of Nyaditum

Resae ® Probiotic Administered to

Pediatric Population in Contact

With Tuberculosis With or Without

Latent Tuberculosis Infection

This is a double-blind, masked, compared with placebo

clinical trial in pediatric population in contact with

tuberculosis with or without tuberculosis infection. This trial

aims to study the effect of the probiotic Nyaditum resae® at

the level of specific Treg memory cells eight weeks after the

first administration, and the global tolerability of the

treatment.

Nyaditum resae® is a preparation in the form of capsules

containing heat-killed environmental mycobacteria

Mycobacterium manresensis. The overall objective of the

study is the effect of Nyaditum resae® on immunity, which

could reduce the risk of developing active tuberculosis.

Treatment/intervention Interventional Phase 1 Allocation:

Randomized, Endpoint

Classification: Safety/Efficacy

Study, Intervention Model:

Parallel Assignment, Masking:

Double Blind (Subject, Caregiver,

Investigator), Primary Purpose:

Prevention

Dietary Supplement: Nyaditum

resae ® 10e5 of heat-killed

Mycobacterium manresensis

Other: Placebo

Spain

Sponsor:

Manresana de Micobacteriologia, SL

Child between 2 and 17 years,

who have had contact with

tuberculosis

24 NCT02581579

Immune Responses to

Mycobacterium Tuberculosis (Mtb)

in People With Latent Tuberculosis

Infection With or Without

Concomitant Helminth Infection

To study how the immune system of people with latent

tuberculosis infection (LTBI) acts to prevent development of

active TB. Also, to study how helminth infection might affect

this immune response. An exploratory objective is to

evaluate if there are subsets of subjects within the LTBI

group (irrespective of helminth infection status) who have

stable pool of long lasting antigen-specific IL-2 only

producing CD4+ central memory T cells and changes to this

pool after receiving LTBI treatment.

Other (immunology,

pathogenesis, co-infection)

Observational

Study Design:


United States Sponsor: National Institute of Allergy

and Infectious Diseases (NIAID)

The study will enrol

participants with LTBI250 NCT02225158

Randomised controlled trial for cost-

benefit of short-course isoniazid

and rifapentine versus 9-month

course of isoniazid in latent

tuberculosis infection

The aim of this study is to perform a multimodal comparison

of 3-month courses of weekly isoniazid and rifapentine (3HP)

with 9 months of daily isoniazid (9H) for latent tuberculosis

infection, using a variety of indices:

a. Cost-benefit

b. Patient satisfaction

c. Adherence to prescribed therapy

Programme management Interventional Randomised controlled trial

Parallel

Phase: Phase 4

A 12 dose course of weekly

isoniazid (900mg) and rifapentine

(900mg) tablets.

Australia Sponsor: Hospital Melbourne Health

Persons with clinical indication

for latent tuberculosis infection

(LTBI) treatment.

80 ACTRN12613000599774

Effect of Filarial Infection on

Immune Responses in Latent

Tuberculosis

Researchers want to study people with latent tuberculosis

(TB) who may or may not be infected with filariasis. This

study will look at the way that people with latent TB fight

infection with these worms.

Other (immunology,


Observational Time Perspective: Cross-Sectional not provided United States Sponsor:



Eligibility:

- Individuals between 18 and

65 years of age who have

latent TB and may or may not

have filarial infection.

4000 NCT01547884

TB mHealth Study - Use of Cell

Phones to Improve Compliance in

Patients on LTBI Treatment

This study will examine the impact of use of mobile phones

and text messaging on adherence to treatment for patients

with latent TB infection. Half (50%) of the 350 anticipated

study participants will receive weekly text messages

inquiring on their health status in relation to their prescribed

treatment, while the other half (50%) will not receive weekly

text messages at all. Medical adherence will be assessed by

monthly blood-work, clinic visits and by interviewing

patients at each of these visits.

The investigators hypothesis is that enhanced

communication with a health care provider, via a structured

cell phone SMS text messaging based program (WelTel), will

result in a 15% improvement in the proportion of patients

who successfully complete their LTBI treatment regimens.

Adherance and completion

in treatment

Interventional Phase 0 Allocation:

Randomized

Intervention Model: Single Group

Assignment

Masking: Open Label

Primary Purpose: Health Services

Research

Other: Cell phone text messages

Participants in the intervention

arm will receive weekly text

messages from the TB control clinic

asking how they are.

Canada Sponsor:

University of British Columbia

Collaborator:

British Columbia Cancer AgencyInclusion Criteria:

Are initiating treatment for

latent TB infection350 NCT01549457

Evaluating the Safety and

Effectiveness of Short-Course

Rifapentine/Isoniazid for the

Prevention of Active Tuberculosis in

HIV-Infected Individuals With Latent

Tuberculosis Infection

HIV-infected people have an increased risk of developing

active tuberculosis (TB). The standard course of treatment

for TB is 6 to 9 months of isoniazid (INH). A shorter course of

treatment may be as effective and potentially increase

treatment adherence. This study will compare the safety and

effectiveness of a 4-week regimen of rifapentine (RPT) plus

INH versus a standard 9-month regimen of INH in HIV-

infected people who are at risk of developing active TB.


Randomized, Intervention

Model: Parallel Assignment,

Masking: Open Label, Primary

Purpose: Prevention

Dietary Supplement: Pyridoxine

(Vitamin B6)

Drug: Isoniazid (INH)

Drug: Rifapentine (RPT)

United States, Botswana,

Brazil, Haiti, Kenya,

Malawi, Peru, South

Africa, Thailand,

Zimbabwe

Sponsor:


Infectious Diseases (NIAID) HIV + persons with latent TB 3000 NCT01404312

Training Protocol on the Natural

History of Tuberculosis

To provide better training for infectious disease staff

members at the National Institutes of Health Clinical Center

in Washington, D.C., researchers are interested in actively

recruiting individuals with TB for research and treatment

studies. Objectives:

•To provide staff at the National Institutes of Health Clinical

Center with increased experience in hands-on treatment of

individuals with tuberculosis, including drug-sensitive or

drug-resistant forms of the disease.

•To collect blood and other samples to study the natural

history of tuberculosis.

Programme management

Observational

Time Perspective: Prospective United States Sponsor:



150 NCT01212003

Prospective Study of

Mycobacterium Tuberculosis

Specific Cellular immune Responses

in Iatrogenically Immunosuppressed

Patients: those undergoing TNF-

alpha blockade or Awaiting Renal

Trasnplants: A Potential New

Method For Accurate Diagnosis of

Latent Tuberculosis Infection in

Clinical Practice

To validate the use of the RD1 based Exvivo IFNy ELISpot in

the immunodiagnosis of tuberculosis in iatrogenically

immunosuppressed populations by calculation of positive

and negative predictive values for the assay and for a

comparator: the tuberculin based mantoux test.

To investigate potential immune correlates of latency and

active disease in tuberculosis and identify potential markers

of prognosis and disease progression in tuberculosis.



and biomarkers

Observational The RD1 based ex vivo enzyme

linked immunospot assay versus

Tuberculin PPD RT 23 SSI for

mantoux testing

UK-multicentre Sponsor: University of Oxford

Renal failure and iatrogenic

immunosuppression associated

with solid organ

transplantation or TNF alpha

blockade in rheumatoid

arthritis

EudraCT Number: 2005-

005664-88

The V-QUIN MDR TRIAL: A

randomized controlled trial of six

months of daily levofloxacin for

the prevention of tuberculosis

among household contacts of

patients with multi-drug resistant

tuberculosis

To assess the efficacy of preventive therapy (levofloxacin

versus placebo) in all contacts (adults and children)

Treatment/intervention/M

DR

Interventional

Randomised controlled trial

Parallel

Six months of daily oral

levofloxacin

Vietnam NHMRC, Vietnam National

Treatment Program

Household contacts (adults,

adolescents, and children

down to 3 kg) of individuals

with MDR-TB

2006 ACTRN126000215426

TB-CHAMP

To assess the efficacy of

levofloxacin in the prevention of

MDR-TB in child and adolescent

household contacts of MDR-TB

cases.

The lack of evidence on MDR-TB preventive therapy

makes it difficult to develop evidence-based guidelines,

leading to 'recommendations' based on opinion only. If

proven to be efficacious, safe, cost-effective, and

acceptable to families and the NTP, we anticipate that this

trial will inform global guidelines for post-exposure

preventive therapy in child and adolescent contacts of

MDR-TB.

Treatment/intervention Interventional Multi centre phase III, double

blind RCT

24 weeks of daily levofloxacin

against 24 weeks of daily placebo

South Africa Joint Global Health Trials Scheme of

the Department for International

Development (UK), Wellcome Trust,

Medical Research Council, South

African Medical Research Council

Child <5 years who is

household contact of an

enrolled adult MDR-TB case

1556 ISRCTN92634082

Prospective Comparison of the

Tuberculin Skin Test and

Interferon-Gamma Release Assays

in Diagnosing Infection With

Mycobacterium Tuberculosis and

in Predicting Progression to

Tuberculosis

This is a prospective cohort study of persons tested for

latent tuberculosis infection at either high risk for

exposure to Mycobacterium tuberculosis or high risk for

progression to tuberculosis disease. The study will assess

the relative performance and cost of three diagnostic tests

for latent tuberculosis infection (tuberculin skin test,

QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will

examine the rates of positive results among the cohort.

This study will also determine the risk and rate of

progression to active TB disease, overall and by the

results of the three tests.



Observational Observational Model: Cohort


not provided 10 sites across the

United States

Tuberculosis Epidemiologic Studies

Consortium II (TBESC II)

High risk individuals for

latent TB, including children

and immunocompromised

persons.42647 NCT01622140

Randomized Clinical Trial

Comparing 4RIF vs. 9INH for LTBI

Treatment-effectiveness

The current standard regimen is 9 months of Isoniazid

(9INH). This regimen has excellent efficacy if taken

regularly, but its effectiveness is substantially reduced by

poor compliance. Based on some evidence in treatment of

LTBI, and extrapolating from extensive experience with

treatment of active TB, it is believed that 4RIF has similar

efficacy as 9INH. Therefore, the investigators are

initiating the first multi-site international randomized

trial that will compare the effectiveness of 4RIF and 9INH

in preventing active tuberculosis.


Randomized


Efficacy Study


Assignment

Masking: Open Label

Primary Purpose: Treatment

Isoniazid versus Rifampin Australia, Benin,

Brazil, Canada, Ghana,

Guinea, Indonesia,

Korea, Republic of,

Saudi Arabia

ponsor:

McGill University

Collaborator:

Canadian Institutes of Health

Research (CIHR) Principal

Investigator: Dr. Dick Menzies5720 NCT00931736

A Randomized Trial to Compare

Effectiveness of 4 Months

Rifampin (4 RIF) With 9 Months

Isoniazid (9 INH) in the

Prevention of Active TB in

Children: The P4v9 Trial

Once children are exposed and infected they are at very

high risk to develop active TB - which can be lethal if not

detected and treated promptly. This makes it very

important to detect TB infection as soon as possible, and

treat this while it is still latent or dormant. Current

therapy for latent TB infection is 9 months of Isoniazid;

this is very effective if taken properly but because

treatment is so long many children do not finish this. Four

months of Rifampin is a recommended alternative. It is

hypothesized that among children at high risk for

development of active TB, intolerance/adverse events will

not be worse (non-inferiority), among those randomized

to 4RIF compared to those randomized to 9INH. In

addition completion of latent tuberculosis infection

(LTBI) therapy will be significantly greater (superiority),

and subsequent rates of active TB will not be significantly

higher (non-inferiority) in children taking 4RIF.

Treatment/intervention Interventional Phase 3

Allocation: Randomized

Endpoint Classification: Safety

Study


Assignment

Masking: Open Label

Primary Purpose: Treatment

Drug: Isoniazid verus Rifampin Australia, Benin,

Brazil, Canada, Ghana,

Guinea, Indonesia

Sponsor:

McGill University

Collaborator:

Canadian Institutes of Health

Research (CIHR)

Information provided by

(Responsible Party):

Dr. Dick Menzies, McGill University

Children (age <18) with

documented positive TST (or

in the absence of TST, a

positive QFT or T-Spot) and

prescribed preventive

treatment for LTBI

822 NCT00170209

Predictive Values of Next

Generation Interferon Gamma

Release Assays for Latent


Currently available blood tests for latent tuberculosis

infection (LTBI) identify people who have been previously

infected with M. tuberculosis. Whilst they are sensitive

and specific, they cannot be used to monitor the

effectiveness of treatment for LTBI. New blood tests

("fourth generation Quantiferon tests") have not yet been

evaluated in clinical practice, so their usefulness in

identifying people at highest risk of TB disease and

monitoring treatment is unknown.



Interventional Single Group Assignment

Open Label

Primary Purpose: Diagnostic

Procedure: blood test, not yet

marketed, no trade name

blood test using the new TB

diagnostic test

UK Sponsor:

Public Health England

Collaborator:

University College, London

Adult contacts of

smearpositive pulmonary TB

patients and patients with

active TB. Hajj pilgrims:

Individuals arranging travel

to Saudi Arabia for the Hajj

through participating tour

operators.

2000 NCT02512939

Early Detection and Management of

Tuberculosis in the EU.

E-DETECT TB

Establishing a database of latent and active TB in Europe

starting with Italy, Sweden, the Netherlands and the UK to

inform epidemiological analysis and future interventions to

control TB.

Programme management Observational Cohort Latent TB testing and treatment

programmes

Multiple: UK,

Netherlands, Sweden,

Italy, Romania and

Bulgaria

EU Third Health Programme

Chief investigator : Ibrahim Abu bakarVarious https://e-detecttb.eu/

CATAPULT Treatment of latent TB in primary care compared to

secondary care

Programme management Observational A cluster randomised controlled

trial

Treatment of LTBI in primary care UK Barts Charity

Chief investigator: Heinke Kunts

Co-aaplicant: Ibrahim AbubakarMigrants 780 NCT03069807

Prognostic Study of the Interferon

Gamma Release Assay for

Tuberculosis (UK PREDICT TB)

Predictive value of the two commercial IGRAs compared to

TST



Observational Cohort Two commercial IGRAs (T-Spot TB

and Quantiferon, TST)

Biobank for substudies

UK Chief investigator: Ibrahim Abubakar

Contacts, Migrants 10,000 NCT01162265

Optimising approaches for LTBI

screening and preventive

treatment. ZonMW

TB ENDPoint

Lessons learned from the different pilots will be used to

improve intervention within the specific target population.

Quantitative results from the pilots on uptake of LTBI

screening and PT will be used as input to assess the long

term impact in terms of costs and cases averted with

different LTBI strategies.

Programme management Observational

Multiple pilot studies Prospective

cohortLTBI intervention

The Netherlands ZonMw (The Netherlands

Organization for Health Research and

Development) – Govt institution.

KNCV, RIVM, Municipal Health

Services, Universities

• Regular immigrants

• Asylum seekers

• Somali and Eritrean

population

http://www.zonmw.nl/nl/p

rojecten/project-detail/tb-

endpoint-tuberculosis-

elimination-in-the-

netherlands-through-

disease-prevention-

optimalization/samenvatti

ng/

Evaluation of contact investigation

in the Netherlands (2006-2013).

Study is based on a previous evaluation report (2016-2010)

with more than 60,000 contacts screened (45,000 for LTBI)

and 3,050 LTBI cases identified.

Programme management ObservationalRetrospective cohort Evaluation

The Netherlands KNCV LTBI cases

>60,000 contacts

screened??

To evaluate the predictive value of

IGRA results from 2008 - 2011 as a

predicitve marker for progression to

tuberculosis.

Assessing predicitive value of IGRA and to understand the

contributing risk factors towards progression of disease.



Observational

Retrospective cohort Evaluation

The Netherlands

KNCV LTBI cases 4000 ??

Enhancing the public health impact

of latent tuberculosis (TB) infection

diagnosis and treatment (ACT4)

The trial test a complex intervention- a two phase

programmatic public health package which includes a

standardized public health evaluation and analysis, to

identify problems and barriers limiting LTBI diagnosis and

treatment among close contacts or active TB cases.

Programme management Interventional Allocation: Randomized


Assignment

Masking: Open Label


LTBI program evaluation &

diagnosis

Benin, Brazil, Canada,

Ghana, Indonesia,

Vietnam

Sponsor: McGill University

Collaborators: Canadian Institutes of

Health Research (CIHR)

LTBI cases among household

contacts of patients with active

pulmonary TB

36 NCT02810678

https://e-detecttb.eu/

http://www.zonmw.nl/nl/projecten/project-detail/tb-endpoint-tuberculosis-elimination-in-the-netherlands-through-disease-prevention-optimalization/samenvatting/








Promoting adherence to treatment

for latent TB infection through text

messaging

The purpose of this study is to determine whether regularly

scheduled reminder text messages (SMS) are effective in

increasing LTBI treatment completion.



Assignment

Masking: Single Blind


Regularly scheduled LTBI

medication reminder text

messages

United States

Sponsor: University of Arizona

Collaborators: Pima County Health

Department, American Lung

Association

Adult LTBI cases 250 NCT02690818

Screening latent tuberculosis

infection and observing preventive

therapy in kidney transplantation

Study the prevalence of LTBI in patients who are waiting

renal transplant and monitor the incidence of active TB.

Programme management observational Allocation: Randomized




Assignment

Masking: Open Label

Primary Purpose: Screening

Screening for LTBI in patients who

are waiting renal transplant and

monitor the incidence of active TB.

Taiwan

Sponsor: National Taiwan University

HospitalRenal transplant patients 800 NCT02782416

Impact of Once-Weekly Rifapentine

and Isoniazid on the Steady State

Pharmacokinetics of Dolutegravir

and Darunavir boosted with

cobicistat in healthy volunteers

The purpose of this study is to determine the effects of

concomitant RPT and INH administration on the steady state

PK of DTG and DRV/c. The use of weekly RPT plus INH is not

currently recommended in adults infected with human

immunodeficiency virus (HIV) on antiretroviral therapy (ART)

due to limited evidence on drug interactions with

antiretrovirals (ARVs). Dolutegravir (DTG) and darunavir

boosted with cobicistat (DRV/c) comprise parts of first-line

Treatment/intervention Interventional Endpoint Classification:

Pharmacokinetics/Dynamics

Study


Assignment

Masking: Open Label

dolutegravir (DTG); rifapentene

(RPT); darunavir/cobicistat (DRV/c);

Isoniazid (INH)

United States National Institutes of Health Clinical

Center

Healthy volunteers 60 NCT02771249

Taima TB: 3HP Study The primary objective of this study is to compare the

proportion of people who complete directly observed

prophylactic treatment (DOPT) using the new 3HP regimen

to the current standard of 9 months INH

Treatment adherance Interventional Phase IV


Assignment

Masking: Open Label


3 HP Canada Sponsor: Ottawa Hospital Research

Institute

Collaborators: Government of

Nunavut, Government of Canada LTBI diagnosed people (2-65

years) with either TST or IGRA450 NCT02689089

The correlate of risk targeted

intervention study (CORTIS)

A prognostic correlate of risk (COR), based on messenger

ribonucleic acid (mRNA) expression signatures, which

prospectively discriminates between TB cases and healthy

controls, has been constructed and validated. Test whether

preventive therapy (3HP) reduces the rate of incident TB

disease, compared to standard of care (active surveillance),

in COR+ persons.

Test whether COR status differentiates persons with

cumulative prevalent or incident TB disease from persons

without TB disease.



and biomarkers





Assignment

Masking: Open Label


Isoniazid, Rifapentine Sponsor: University Cape Town

Collaborators: South African TB

Vaccine Initiative, Aurum Institute,

Centre for the AIDS Programme fo

Research in South Africa, University of

Stellenbosch, London School of

Hygiene and Tropical Medicine, Fred

Hutchinson Cancer Research Center

Aged between 18 and 60, with

known COR and HIV status.3200 NCT02735590

New generation IGRA in

immunocompromised individuals

(Tbnet#54)

Evaluates the performance of a new ELISA based

QuantiFERON-TB plus in-tube test to identify M.tuberculosis

specific immune Responses as evidence of latent infection

with M.tuberculosis in immunosuppressed populations.





QuantiFERON TB plus in-tube test Germany, Italy, Republic

of Moldova, Norway,

Poland, Portugal,

Romania, Spain, United

Kingdom

Tuberculosis Network European

TrialsgroupImmunocompetent and

immunocompromised patients

with and without risk factors

for prior exposure with M.

tuberculosis

2000 NCT02639936

Testing for Tuberculosis in the

United Kingdom HIV infected

Population

We itend to test a cohort of HIV infected subjects for latent

TB infection in HIV infected individuals to assess the cost-

effectiveness of systematic TB screening and the use anti-TB

antibiotics to prevent reactivation of TB.

Programme management Observational Observational Model: Cohor


IGRA, TST, chest x-ray, sputum, United Kingdom Investigator: Marc Lipman

Sponsor: University College, London

Patients attending an

ambulatory clinic for HIV care

in London, HIV, latent

Tuberculosis

300 NCT02712671

Comparing consistency of

QuantiFERON TB gold plus and

QuantiFERON TB gold for latent

tuberculosis in dialysis population

In patients receiving long term dialysis, using new generation

of QuantiFERON-TB Gold Plus can have less result variability

in inter-experiment and serial follow up in comparing with

QuantiFERON-TB gold in tube.



Observational Observational Model: Cohort,


Examination of LTBI by

QuantiFERON TB

Taiwan Chin-Chung Shu

Patients on dialysis 200 NCT02782494

Efficacy of weekly rifapentine and

isoniazid for tuberculosis

prevention

This is an open-label, randomized, Phase III clinical trial to

evaluate the effectiveness and tolerability of the 3RPT/INH

to prevent tuberculosis compared with those who do not

receive preventive treatment among silicotic patients.

Treatment/intervention Interventional Phase 3





Assignment

Masking: Open Label


Weekly INH/RPT given by DOT China Sponsor: Huashan Hospital

Male adult

Silicosis566 NCT02430259

A5300/I2003 PHOENIx Study PHOENIx is a Phase III trial in development by the ACTG

and IMPAACT networks to assess the efficacy of 6

months of daily delamanid (novel intervention arm)

versus 6 months of isoniazid preventive therapy (control

comparison arm) in high -risk household contacts of adult

pulmonary MDR TB cases.

Treatment Interventional Phase 3 efficacy of 6 months of daily

delamanid (novel intervention

arm) versus 6 months of isoniazid

preventive therapy (control

comparison arm) in high -risk

household contacts of adult

pulmonary MDR TB cases

Botswana (1)

Brazil (1)

Haiti (1)

Kenya (1)

India (2)

Peru (2)

South Africa (8)

Tanzania (1)

Thailand (2)

JHU Treating HIV-infected and

other child,

adolescent

and adult household contacts

of MDR TB

patients, including pre

-XDR TB and XDR TB,

who are at high risk of

developing TB.

3,452

A5300/I2003

http://www.impaactnetwo

rk.org/studies/IMPAACT20

03B.asp

Screening for Latent Tuberculosis

Infection (LTBI) in US Army Recruits

(LTBI)

The overall objective of this study is to assess the feasibility

and potential impact of using a targeted testing approach

and 2 interferon-gamma release assays (IGRA) to screen for

latent tuberculosis (TB) infection (LTBI) among military

recruits. The current policy of universal application of the

Mantoux tuberculin skin test (TST) to screen for LTBI may

Programme management observational Intervention Model: Single Group

Assignment


Outcomes Assessor)

Primary Purpose: Screening

Drug: BST

0.1 mcg/mL (1 dose) Battey skin

test (BST) antigen administered

using the Mantoux method.

Drug: TST

Administer TB Skin test (TST)

USA Uniformed Services University of the

Health Sciences

Infectious Diseases Clinical Research

Program

Soldiers 1781 NCT00804713

TB mHealth Study - Use of Cell

Phones to Improve Compliance in

Patients on LTBI Treatment

This study will examine the impact of use of mobile phones

and text messaging on adherence to treatment for patients

with latent TB infection. Half (50%) of the 350 anticipated

study participants will receive weekly text messages

inquiring on their health status in relation to their prescribed

treatment, while the other half (50%) will not receive weekly

text messages at all. Medical adherence will be assessed by

Treatment adherence Interventional Study Type: Interventional

Study Design: Allocation:

Randomized


Assignment

Masking: Open Label

Primary Purpose: Health Services

Cell phone intervention arm:

Upon consent, participants will be

randomly assigned to receive

either 1) standard of care (9

months of INH or 4 months of RIF)

and weekly SMS text messages via

mobile phone or 2) standard of

Canada University of British Columbia

British Columbia Cancer Agency Persons initiating treatment for

latent TB infection over the age

of 18 years old, owning a

mobile phone or share access

mobile phone access AND

demonstrate sufficient ability

350 NCT01549457

MTBVAC Study in Adults With and

Without Latent Tuberculosis

Infection in South Africa (A-050)

MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x

10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x

10^5 CFU). Participants will receive a single dose of MTBVAC

or BCG revaccination administered intradermally on Study

Day 0.

Vaccination Interventional Phase 1b/2a, double-blind,

randomized, BCG-controlled,

dose-escalation safety and

immunogenicity study.

Participants meeting the

inclusion/exclusion criteria will be

randomized within a study cohort

to receive a single dose of MTBVAC

or BCG revaccination administered

intradermally on Study Day 0.

TParticipants will be randomized

within each cohort, to receive

either MTBVAC (N=96) or BCG

South Africa Aeras

Biofabri, S.L

Universidad de Zaragoza

South African Tuberculosis Vaccine

Initiative

TuBerculosis Vaccine Initiative

Persons of both sexes 18-50

years old, ho have recieved a

prebious BCG vaccination. IGRA

positive or negative.

120 NCT02933281

The Role of IGRA in Screening and

Monitoring for TB During Anti TNF

Therapy in Patients With IMID

(IGRA)

This study aims to investigate the role of IGRA in screening

for latent TB in IBD patients and control subjects. In part II of

the study, patients of other immune-mediated inflammatory

diseases (IMID) will also be included to investigate the role

of serial interferon-gamma release assays (IGRA) for the

diagnosis of tuberculosis (TB) infection in patients with

immune-mediated inflammatory diseases (IMID) treated

with biologics.


Observational Model: Case

Control. Time Perspective:

Prospective

Part I of this study aims to

investigate the role of IGRA in

screening for latent TB in IBD

patients and control subjects. Part

II of this study is a prospective

study of serial interferon-gamma

release assays (IGRA) for the

diagnosis of tuberculosis (TB)

infection in patients with immune-

mediated inflammatory diseases

Hong Kong Chinese University of Hong Kong

Patients aged 18 years or

older

patients with a diagnosis of

Crohn's disease (CD) or

ulcerative colitis (UC) for at

least 3 months defined by

histology or radiology

560 NCT02135289

Performance of IGRAs for TB

Infection Diagnosis in Elderly

(IGRage)

TB-infection diagnosis based on immunological memory detection

can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB)

specific for MTB infection have not been evaluated in those old

patients.The primary endpoint of this study is the evaluation of

the IGRAS for active TB diagnosis in patients above 75 years old.The

aim of this study is to evaluate characteristics of the two

commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in

tube® and TST in old patients with or without active Tuberculosis.



Observational Observational Model: Case-

only. Time

Perspective: Prospective

Diagnostic test performance study;

3 tests performance for active TB

diagnosis in patients older than 75

years-old. Concordance between

IGRAs. Non-concordant results

analysis concordance of IGRAs

results with time of TB-infection

biobank

Paris, France Assistance Publique - Hôpitaux de

Paris

Persons aged > 75 years, birth

before 1935, with suspected Tb

disease.

160 NCT01895582

Primary Prophylaxis for Prevention

of TB in Prison's Populations

To determine if isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity

of the disease.

Treatment Interventional Randomized

Intervention Model: Parallel AssignmentEach subject in the treatment

group will receive two oral

supervised weekly doses of

isoniazid 900 milligram for 52

weeks.

Dourados, Brazil Federal University of Mato Grosso do

Sul

Inclusion Criteria:Minimum

stay estimated at 24 months

under a closed regime, without

active tuberculosis or previous

use of rifapentine or isoniazid,

without consuming alcohol at

least 3 months

728 NCT03028129

IGRA and Mantoux Response in

Children With Suspected Latent or

Active TB Infection (TBTubercolar)

The aim of this project is to analyze the potential

contribution of IGRA test QuantiFERON-TB Gold In Tube test

(QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in

the diagnosis of tuberculosis (TB - active or latent) in

pediatric subjects (0 and 17 year)s recently exposed to

infection (indicated as "contacts") or with clinical suspicion

of active TB, and to compare the results obtained with those

of the TuberculinSkin Test (TST; gold standard).



Observational Observational Model: Case-Only Primary Outcome Measures:

Number of patients with

concordance of QTF-GIT test and

TST,among children exposed to TB

[ Time Frame: up to 4 years ]

Number of patients with

positivity of QTF-GIT in comparison

with TST among children with

active tuberculosis disease [ Time

Frame: up to 4 years ]

Number of patients with a

negative QTF-GIT test in

comparison of TST, among non-

infected children [ Time Frame: up

to 4 years ]

Siena, Italy University of Siena Children and young adults

between 0 to 17 years

Contact with TB case and/or

clinical suspect of active TB

50 NCT02653404

Diagnosis of Tuberculosis in Swiss

Children (CITRUS)

The primary objective is to improve the sensitivity of novel

immunodiagnostic tests for detection of TB disease in

children.The secondary objective is to determine biomarkers

that discriminate children with TB infection and disease.



and biomarkers



Secreted cytokine assay for

persons with LTBI, exposure to

active Tb or with active TB.

Cytokines will be measured using a

bead-based multiplex assay reader

(MAGPIX, Luminex Crop., Austin,

USA).

Basel, Bern, Lausanne

Zurich, Switzerland.

University Children's Hospital Basel Children / adolescents < 18

years of age undergoing

evaluation for TB exposure,

infection or disease. No healthy

individuals included.

190 NCT03044509

Evaluation of PET/MRI Using a

Somatostatin Analog Tracer as a

Novel Approach to Detecting

Pathology in High Risk TB-exposed

Contacts

PET/MRI (positron emission tomography/magnetic

resonance imaging) with somatostatin analog tracers has the

potential to provide an imaging technique targeting

subclinical granulomatous disease in those with latent

tuberculosis (TB), allowing identification of individuals who may be

at risk of progression to active TB.



and biomarkers

Interventional Intervention Model: Single

Group Assignment

Radiation with either an FDG ligand

(other Name: 18F-Fludeoxyglucose)

or with

DOTANOC ligand (other Name:

68Ga-DOTANOC) will beperformed

and standard uptake values (SUV)

Singapore National University Hospital,

Singapore

21 Years and older (Adult,

Senior) with TB exposure, LTBI

or active TB.

30 NCT02967666

The Correlate of Risk Targeted

Intervention Study (CORTIS)

Effective tuberculosis (TB) control requires that people who

progress from latent Mycobacterium tuberculosis (MTB)

infection (LTBI) to TB disease are identified and treated

before they infect others. A prognostic correlate of risk

(COR), based on messenger ribonucleic acid (mRNA)

expression signatures, which prospectively discriminates

between TB cases and healthy controls, has been

constructed and validated. Based on published microarray

case-control datasets, the COR has 87% diagnostic sensitivity



and biomarkers

Observational Randomized


Assignment

Drug: Isoniazid: Participants in the

Treatment Arm will receive high

dose Isoniazid - 15mg per kg body

weight, rounded up to the nearest

100 mg; maximum dose 900 mg

with Pyridoxine supplementation

(25mg) and Rifapentine based on

body weight (>32kg - 50kg: 750 mg;

>50kg: 900 mg), given weekly as 12

Cape town, SA Sponsor:

University of Cape Town

Collaborators:

South African Tuberculosis Vaccine

Initiative

Aurum Institute

Centre for the AIDS Programme of

Research in South Africa

University of Stellenbosch

Ages Eligible for Study 18 Years

to 60 Years (Adult), all sexes,

healthy Volunteers accepted.

3200 NCT02735590

MVA85A Aerosol vs Intramuscular

Vaccination in Adults With Latent

Mycobacterium Tuberculosis (M.

tb) Infection

A Phase I Trial to Compare the Safety and Immunogenicity of

Candidate TB Vaccine MVA85A Administered by the Aerosol

Inhaled Route and the Intramuscular Route in Healthy Adult

Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis

Vaccine Interventional Allocation: Randomized


Assignment

Masking: Participant, Care

Provider, Investigator, Outcomes

Assessor

Primary Purpose: Other

Biological: Aerosol inhaled

MVA85A or

intramuscular MVA85A or

intramuscular Saline placebo or

aerosol inhaled Saline placebo

UK University of Oxford

Study Director: Helen McShane

University of Oxford

Principal Investigator: Paul Moss


Principal Investigator: Marc Lipman

Royal Free Hostpital

Principal Investigator: Felicity Perrin

King's College Hospital NHS Trust

Ages Eligible for Study: 18

Years to 55 Years (Adult)

Sexes Eligible for Study: All

Accepts Healthy Volunteers:

Yes

15 NCT02532036

ENhance Initiation and Retention in

Isoniazid Preventive Therapy (IPT)

Care for HIV Study (ENRICH Study)

(ENRICH)

To evaluate a combination intervention package (CIP)

designed to improve implementation of Isoniazid Preventive

Therapy (IPT) among people living with HIV (PLWH) in

Ethiopia.



Assignment. The study is a two-

arm cluster randomized trial,

randomized at the HIV clinic

level, which includes 10 HIV

clinics in Dire Dawa and Harari,

Ethiopia. Clinics are randomized

to deliver the combination

intervention package (CIP) or

standard of care (SOC), with

stratification by facility size (<80

or >80 patients enrolled in HIV

care per year)

Behavioral: Combination

intervention components

Drug: Isoniazid Prevention Therapy

The experimental intervention will

be delivered to all patients in HIV

clinics randomly assigned to CIP

who initiated HIV care at the CIP

site on or after January 1, 2013 and

initiated IPT on or after date of

study initiation, July 1, 2013. In HIV

clinics assigned to SOC, usual care

procedures for provision of IPT will

be delivered.

Ethiopia Sponsor:

Columbia University

Collaborator:



Sexes Eligible for Study: 338

NCT01926379

Latent Tuberculosis Infection in

Korean Health Care Workers Using

Interferon Gamma Releasing Assay

To determine the proportion of Korean Health Care worker

using the IGRA

Programme management Observational Single Group Assignment, Masking:

Open Label, Primary Purpose:

Screening

QFT-IT Test and other blood sampling Korea, Republic of Hanyang University, Korea, Republic of

- Health care workers in University

affiliated hospital

- Adult aged 20-65

240 NCT03010111

Rifampin versus isoniazid for the

treatment of latent tuberculosis

infection: Part 3 effectiveness

A randomised clinical trial comparing 4 months of rifampin to 9

months of isoniazid for the treatment of latent tuberculosis

infection: To compare the cumulative incidence during 28 months

after randomisation, of confirmed active tuberculosis (TB) among

all persons randomised (effectiveness, using intention to treat

analysis) to 4RIF and 9INH

Treatment/intervention

Interventional Multicentre randomised two-arm

positive controlled open-labelled

clinical trial (Treatment)

Rifampin (drug) and isoniazid (drug).

The dosage of the medication is

determined according to the weight of

the subject:

Isoniazid: once per day, in pill format,

for a total daily dose of 300 mg if

subject weighs greater than or equal

to 42 kg, otherwise 200 mg. Total

Australia Benin Brazil

Canada Ghana Guinea

Indonesia Korea, South

Saudi Arabia

The Research Institute of the McGill

University Health Centre (Canada)

Adults (aged greater than 18

years, either sex) with

documented positive tuberculin

skin test (TST) and prescribed

9INH for LTBI, following

authoritative recommendations.

Ecluding amongst others PLHIV.

5720 ISRCTN05675547

Correlation of the Precursor

Frequency of CD4 + Effector

Memory T Cells With Induration

Measured in the Tuberculin Skin

Test (TST)

The purpose of the present study is to evaluate the latent form of

this infection, the prevalence of which worldwide exceeds that of

active disease. Our hypothesis is that in latent tuberculosis antigen

specific effector memory CD4+ T cells are responsible for the

generation of clinically measurable delayed type hypersensitivity

and that central memory CD4+T cells are not directly involved in

this process. We base this idea on the assumption that latent

tuberculosis is a state of antigen persistence and that effector

memory T cells should be maintained as long as antigen/infection

is present.

Other (immunology,


Observational NP NP Mali, West Africa

Persons18 Years and older

(Adult, Senior), both sexes32 NCT00257907

A Phase I Trial to Compare the

Safety and Immunogenicity of

Candidate TB Vaccine MVA85A

Administered by the Aerosol

Inhaled Route and the

Intramuscular Route in Healthy

Adult Volunteers Who Are Latently

Infected With Mycobacterium

Tuberculosis

TB040 is a clinical trial to investigate and compare the effects of a

candidate Tuberculosis (TB) vaccine, MVA85A, administered by

the aerosol inhaled route and the intramuscular route in healthy

adult volunteers who are latently infected with Mycobacterium

tuberculosis.Treatment/intervention

Interventional


Endpoint Classification: Safety

Study


Assignment


Caregiver, Investigator,

Outcomes Assessor)

•Biological: Aerosol inhaled

MVA85A

Other Name: MVA85A

•Biological: Intramuscular

MVA85A

Other Name: MVA85A

•Biological: Intramuscular Saline

placebo

UK

Sponsor:

University of Oxford

Collaborator:


30

NCT02532036

The HALT-LTBI study: Phase IV,

multi-site, unblinded, randomised

trial of prophylactic daily

rifampicin/isoniazid vs. weekly

rifapentine/isoniazid for latent

tuberculosis infection (LTBI)

To assess completion rates of two different LTBI treatment

regimens (daily rifampicin/isoniazid, the current UK standard

treatment, vs weekly rifapentine/isoniazid). The objective of the

pilot phase would be to assess feasibility and safety.

Treatment/intervention Interventional Unblinded RCT Random allocation to either Rifinah

(Rifampicin plus Isoniazid) or

Rifapentine and Isonazid.

UK-multicentre Sponsor: University College London

Latent tuberculosis infection 100 ISRCTN04379941

Developing a partnership to inform UK-Brazil TB control: Investigating the efficacy of BCG vaccination following latent tuberculosis treatment.To evaluate the effect of BCG vaccination after treatment of latent TB infectionTreatment/intervention Interventional Pilot trial BCG vaccine after treatment of LTBI, serial IGRA BrazilMRC Principle investigator (UK): Ibrahim Abubakar, Brazil (Sergio Arruda) ??

Next Generation Tests for Latent Tuberculosis and Predicting Active Tuberculosis.Prognostic value of the next generation quantiferon test and biomarkers for progressionDevelopment of new tests with improved performance and biomarkers Observational Cohort IGRA (4th Gen)Biobank for substudies UK Multi-CentreNIHR,University College London Chief investigator: Ibrahim AbubakarAdult contacts of pulmonary TB 2000 ??

Effectiveness Of Testing For And Treatment Of Hard-To-Reach Groups For Latent Tuberculosis, Hepatitis B Virus And Hepatitis C Virus In England.The impact and value for money of peer support to improve clinical engagement inhard-to-reach individuals with hepatitis C virus (HCV) will be assessed.Assessment of completion rates for a novel, short, LTBI treatment regimen.Adherance and completion in treatment Observational Cohort IGRA tests UKFunder: UK Department of HealthSponsor: Public Health England Principle investigator: Ibrahim AbubakarContacts, Migrants and others at risk of LTBI ??

Programme grant to control tuberculosis among hard to reach patients in London. (includes an LTBI survey in prisons and injecting drug users)Assess prevalence of latent TB in hard to reach groups Programme management Observational Cross sectional study IGRA UK Funder: NIHRChief Investigator: Andrew Hayward Hard to reach groups ??

Impact, acceptability and cost-effectiveness of identifying infectious diseases amongst migrants in primary care (this includes latent TB screening).Assess prevalence of latent TB in migrants Programme management Observational Cohort IGRA UK Chief Investigator: Manish Pareek Migrants ??

Latent Tuberculosis Infection (LTBI) among migrant workers from third countries in CyprusScreening for latent TB infection in migrants using IGRA and analysis of progression to disease following 6 months IPT.Programme management Observational Prospective cohort LTBI intervention Cyprus Sponsor: Under negotiationCenter for Communicable Disease Control, Makarios III Hospital, Nicosia Pulmonology Clinic, Nicosia General Hosp.University of NicosiaMigrant workers 1000 To be announced

To assess targeting of LTBI treatment in Norway (2008 to 2014)The purpose of the study is to explore risk factors for TB in Norway and assess the targeting of LTBI screening and treatment 2008-2014. The population includes all persons tested with IGRA OR who has been notified to the Norwegian TB register with TB or LTBI treatment in Norway in 2008-2014. These data will be linked to Statistics Norway for demographic data, Norwegian prescription database for prescriptions and the Norwegian Hospital Discharge Database for co-morbidities. Programme management Observational Register-based study Norway Norwegian Health Association (NHA)All cases with an IGRA result (positive and negative) OR TB or LTBI treatment80000 ??

Assess outcome of LTBI treatment

and reasons for non-completion.

Data will include all cases prescribed with LTBI treatment in

Norway in 2016. The data to be collected are to a large extent

consistent with the LTBI Task force suggestions for monitoring and

evaluation, with more detailed data on safety. We will use this as a

pilot for assess the feasibility of routine monitoring of LTBI

treatment outcome.

Programme management Observational Prospective cohort Norway Norwegian Institute of Public Health

(NIPH)

LTBI cases

App 700

Information will soon be

available on the web

Barriers to TB screeningThis is a qualitative study among immigrants run by an NGO (LHL international) aiming to identify barriers to screening for TB.Programme management Observational Qualitative study Norway Norwegian Heart and Lung Association (LHL International) Immigrants 25 ??

Evaluation of LTBI screening policy in the National TB Control Plan (2016-2020).National data collection and analysis of LTBI screening policy, practices and results of clinical risk groups in hospitals, as part of the National TB Control Plan 2016-2020.Programme management Evaluation Prospective Observational The Netherlands KNCV LTBI cases The National TB Control Plan will be published soon (in Dutch) and sent out for translation.

Evaluation of LTBI screeing and

prevention among at risk migrant

populations

Programme management observational Evaluation

The Netherlands KNCV ??

US NIH clinical centre trial

NCT02777229

Impact of 3HP on the steady state pharmacokinetics of

Dolutegravir and Darunavir boosted with Cobicistat in

Healthy Volunteers

Treatment Interventional

NCT02777229

ViiV Healthcare clinical trial[1] (Phase III-

b study)

Concomitant treatment with EFV-based ARV and RIF-containing TB therapy is

demonstrated to be safe and effective however side-effect profile of EFV

overlaps with the rifampicin. This trial is designed to study safety and efficacy of

Dolutegravir or Efavirenz administered with two NRTIs in HIV-1-infected ART-

naïve adults starting WHO-recommended standard treatment for rifampicin-

sensitive TB


NCT02178592

ADVANCE[2] is a USAID funded and Wits Reproductive Health and HIV Institute led trialSupport studies planned with this trial likely to generate more evidence of RIF/DTG and RIF/TAF interactions by September 2019Treatment Interventional

French National Institute for Health

and Medical Research trial in

Cameroon[3] (phase III randomized

controlled trial)

A sub-study as a part of this trial is planned to review the pharmacokinetics of

DTG and EFV 400 use in TB co-infected patients


Improving the Detection of Active

Tuberculosis in Accident and

Emergency Departments (ACE)

This proposal is focused upon early diagnosis, referral

and treatment of active tuberculosis, which has two key

components: 1) ensuring optimal outcome for individuals;

2) contributing to disease control in public health terms

by preventing further spread.

Operational &

programmatic

Observational Prospective cohort Procedure: venepuncture,

sputum collection, xray

venepuncture, sputum collection,

xray

UK Sponsor: Public Health England

Principle investigator: Ibrahim

Abubakar

Individuals at high risk of TB 1000 NCT02512484

3 HP pharmacokinetics when given

with dolutegravir or efavirenz

Pharmacokinetics Interventional 3 HP selfadministered therapy,

single course or on a yearly basis in

high TB burden settings http://www.tbonline.info/me

dia/uploads/documents/tb_c

ab_meeting_report_decembe

r2015_capetown_external_fi

nal.pdf

ACTG 5279: Phase III Clinical Trial of

Ultra-Short-Course

Rifapentine/Isoniazid for the

Prevention

To compare two treatments to prevent active TB in persons with HIV and latent TB Treatment Interventional Randomised. Controlled phase IIIRifapentine, Isoniazid and vitamin B6 (pyridoxine) will be provided while on study. Subjects will take Rifapentine/Isoniazid plus B6 for 4 weeks or Isoniazid plus vitamin B6 for 9 monthsJHU For People who have HIV and Latent Tuberculosis

TBTC Study 37: Shortened RPT regimen for PT Treatment Interventional Randomized, controlled RPT qd for 6 wks vs. RIF qd 4 mo vs. RPT+INH qwk

http://www.tbonline.info/media/uploads/documents/tb_cab_meeting_report_december2015_capetown_external_final.pdf





TBTC Study. An Evaluation of

Adherence to Latent Tuberculosis

Infection (LTBI) Treatment With

12 Doses of Once Weekly

Rifapentine (RPT) and Isoniazid

(INH) Given as Self-administered

(SAT) Versus Directly-observed

Therapy (DOT): iAdhere.

The trial is conducted in patients diagnosed with latent

tuberculosis infection (LTBI) who are recommended for

treatment. The primary objective is to evaluate adherence

to a three-month (12-dose) regimen of weekly rifapentine

and isoniazid (3RPT/INH) given by directly observed

therapy (DOT) compared to self-administered therapy

(SAT).

Operational/treatment

adherance

Interventional

Phase 3





Assignment

Masking: Open Label


•Behavioral: Self Administered

Therapy (SAT)

Self Administered Therapy (SAT)

•Behavioral: SMS reminders

Short Message Service (SMS) text

reminders

•Drug: isoniazid and rifapentine

United States, China,

South Africa, Spain

Sponsor:

Centers for Disease Control and

Prevention

1) persons with a positive

TSTor IGRA AND one of the

following: close contact to

someone with culture

confirmed TB, HIV infection,

or > 2 cm2 of pulmonary

parenchymal fibrosis on chest

X-ray and no prior history of

TB treatment; 2) TST or IGRA

converters 3) Persons with

any other clinical indication

for LTBI treatment (e.g. HIV-

infected close contacts to an

active pulmonary TB cases)

1002 NCT01582711

Evaluation of LTBI management in

the Netherlands (1993-2013).

Description of LTBI recording and reporting system and the

results of 21 years of LTBI monitoring and evaluation,

focusing on trends in target groups for LTBI screening and

preventive treatment (PT) regimens, including PT initiation,

PT completion and PT discontinuation related to the

occurrence of adverse events are explored.

Operational Observational


The Netherlands

KNCV LTBI cases 37,729 ERJ

Risk to develop TB among persons

diagnosed with LTBI in the

Netherland (1993-2013).

Risk to develop TB among persons diagnosed with LTBI in

the Netherlands. This study examines TB incidence among

persons identified with LTBI and determines risk factors

associated with progression to TB among those treated and

untreated.

Risk factors and disease

progression

Observational


The Netherlands

KNCV LTBI cases ERJ

Landscaping on on-going

developments for tests that better

predict progression from latent TB

Disease progression and risk

factors

Guideline

development

??

Target Product Profile (TPP): Test

for Progression of Tuberculosis

Infection

Guide test developers as to key requirements for assays to

better predict progression from infection to active disease

Other (immunology,


Evaluation and

developmental

??

Document to outline trial guideline

to evaluate tests that better predict

progression from latent TB

provide guidance on key study design

requirements when evaluating tests that better

predict progression from infection to active disease

Disease progression and risk

factors

Guideline

development

??

Development of Human Nasal

Challenge Models With Microbial

Constituents and Grass Pollen

The investigators will carry out nasal challenge with bacterial

and viral components and allergens. In this way the nasal

upper respiratory tract mucosa is challenged with stimuli of

the immune system, causing various types of inflammation.

Samples will be taken by blotting the nostril surface and by

scraping off tiny surface samples.

Other (immunology,


Interventional Non-Randomized The nose will be sprayed with a

substance that is a single part of a

bacteria or virus, or with an

allergen.The study employs

noninvasive methods of sampling

using absorptive strips. These strips

look and feel like tissue paper, and

are applied to each nostril for a

period of 1 min. A few pinhead-

sized tissue samples are taken from

inside the nose, using a small

disposable sterile plastic probe that

has a tiny scoop on its end. In the

nasal lining fluid and tissue

samples, measurement will taken

UK Imperial Clinical Respiratory Research

Unit (ICRRU), St Mary's Hospital

Males and females aged 18 to

60 years. Current non-smokers

for last year, maximum of 10

cigs per month, with a smoking

history of <5 pack years

174 NCT02090374

Impact of New Immunological

Diagnosis Tests of Latent Tuberculosis

Before Anti TNF Therapy

The primary endpoint of this study is the evaluation of the theoric

therapeutic impact of the use of new tests for diagnosis of LTBI in

patients before anti TBF therapy

Diagnostic and screening Interventional Single Group Assignment The primary endpoint of this study is

the evaluation of the theoric

therapeutic impact of the use of new

tests for diagnosis of LTBI in patients

before anti TBF therapyBiological:

QFTB-G and T-SPOT.TB tests

France Assistance Publique - Hôpitaux de Paris

Ages Eligible for Study: 18

Years and older (Adult, Senior)

Sexes Eligible for Study: All

Accepts Healthy Volunteers:

No 430 NCT00811343

Evaluation of an Enhanced

Tuberculosis Infection Control

Intervention in Healthcare Facilities

in Vietnam and Thailand (EnTIC)

Evaluation of an Enhanced Tuberculosis Infection Control

Intervention in Healthcare Facilities in Vietnam and Thailand.

Prevalence of latent Tuberculosis infection (LTBI) in

healthcare workers (HCWs) will be at measured at baseline,

and LTBI incidence will be measured among susceptible

HCWs at 12 and 24 months. Secondary outcomes will be

measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In

year three, results will be analyzed and disseminate

Infection control Observational Stratified, matched, cluster-

randomized, controlled trial

Facilities randomized to the

intervention group will receive:

Skills-based training addressing the

hierarchy of TB IC measures, how

to conduct a facility TB IC /risk

assessment; and development,

implementation, and monitoring of

an operational TB IC plan for the

facility. Audits and Feedback of

performance A TB IC

Viet Nam and Thailand Centers for Disease Control and

Prevention

United States President's Emergency

Plan for AIDS Relief

Health care worker; this study

will be conducted at 22

hospitals, 10 in Thailand and 12

in Vietnam

? NCT02073240

Surveillance and Follow-up for

Latent Tuberculosis Infection and

Observation of the Effect of

Prophylactic Latent Tuberculosis

Treatment in Patients With Severe

Chronic Kidney Disease or Receiving

Long-term Dialysis

To follow-up latent tuberculosis infection and evaluate the

risk of developing active tuberculosis in patients with severe

chronic kidney disease or receiving long-term dialysis

§ Observational

Observational Model: Cohort

Time Perspective: Prospective Not provided

Taiwan

Sponsor:National Taiwan University

Hospital

The patients with severe

chronic kidney disease or long

term dialysis

500 NCT01685086

Is Tuberculin Skin Testing Effective

in Screening for Latent Tuberculosis

in Patients With HIV?

HIV infection highly increases the risk of progression of

latent tuberculosis (TB) to active disease that therapy is

recommended for all PPD-positive, HIV-infected patients,

regardless of age. Sensitivity of the PPD testing is, however,

dependent on a normal T cell function.

Therefore, an accurate and reliable method for detection of

latent tuberculosis in patients with HIV is urgently needed.

This prospective study will examine the utility of interferon-


Observational Model: Case

Control


T-Spot.TB test

United States

Sponsor:

North Shore Long Island Jewish Health

System

Adult patients with HIV

confirmed by standard

methods

53 NCT00763295

Determining Risk in Latent

Tuberculosis

Understanding the risk factors that contribute to latent TB

developing into active TB, and whether it is possible to test

for this risk.



and biomarkers

Observational Observational perspective Not provided Korea, Republic of Sponsor: National Institute of Allergy

and Infectious Diseases (NIAID)

Healthy particpants not

exposed to TB, active TB, latent

TB,

1200 NCT01571739

Improving Latent Tuberculosis (TB)

Diagnosis in Thai Children

Objective is to assess the sensitivity and specificity of IGRAs

and TST in screening for latent TB HIV-infected and HIV

uninfected children in Thailand, to improve the diagnosis

and management of latent TB.



Observational

Observational cohort,

prospective

Not provided Thailand Sponsor: South East Asia Research

Collaboration with Hawaii

Collaborators:

•Columbia University

•New York Blood Center

•HIV Netherlands Australia Thailand

Research Collaboration

•Queen Sirikit National Institute of

Child Health

Thai children between the ages

of 2 months and 16 years with

exposure to active TB adult

cases will be referred to the

two study sites for eligibility

screening.

158 NCT00947609

Comparing the Efficacy of Two

Preventive Regimens for Adult

Household Contacts With Latent


Though still an endemic area, the incidence of tuberculosis

(TB) in Taiwan is decreasing in recent years. Further

reduction in TB incidence, or even elimination should rely on

treatment for LTBI. However, which is the cost-effective

screening method or what is the cost-effective regimen in

Taiwan is still unclear.

Therefore, the investigators designed this prospective study

to follow up adult household contacts with LTBI for 2 years

and compare the efficacy of 9-month isoniazid and 4-month


Phase 3, RCT, parallel, open lable,

intervention

4-month rifampin (Experimental)

vs. 9-month isoniazid (Active

comparator)

Taiwan

Sponsor:National Taiwan University

Hospital

Adult household contact of

patients with newly diagnosed,

culture-confirmed pulmonary

tuberculosis

300 NCT01398618

Better Identification of Latent

Tuberculosis Infection Among Israeli

Young Adults by Comparison Skin

Tests and Interferon Gamma

Releasing Assays (IGRA)

The aim of study is to evaluate the prevalence of latent TB in

second generation immigrants from countries with high

incidence of tuberculosis (above 20 of 100,000) compare to

the control native Israelis without a family member who was

born in a country with high incidence of tuberculosis. Using

study questionnaire IGRA and tuberculin skin test the

investigators expect that the second generation immigrants

group will have more positive IGRA test than the control

native group.


Non-Randomized, Single Blind

(Investigator), Parallel

Assignment

Answering the study Questionnaire

and blood sampling for Interferon

gamma release assay (IGRA)

Israel Sponsor:

Sheba Medical Center

Collaborator:

Tel Aviv Lung Association

Second generation immigrants

from countries with high

incidence of tuberculosis

(above 20 of 100,000).

Native Israelis

without a family member who

was born in a country with high

incidence of tuberculosis.

200 NCT02073669

Impact of HIV Infection on Latent

TB Among Patients With HIV-TB Co-

infection

HIV induced altered representation and function of

regulatory T cell subsets (NKT and Treg cells) impair the

protective T cell response against M.tuberculosis and

disrupts LTBI, thus facilitates faster progression and

development of severe forms of clinical TB in HIV-TB co-

infection.

Other (immunology,


Observational

Prospective Not provided

India Sponsor:

Ministry of Science and Technology,

India

Collaborator:

Indian Council of Medical Research

HIV+ve+LTBI HIV+ve+clinical TB

HIV-ve+clinical TB Normal

control

180 NCT00692809

Screening for Latent Tuberculosis in

Healthcare Workers With

Quantiferon-Gold Assay: A Cost-

Effectiveness Analysis

The ministry of health in Israel requires all health-care

workers to undergo screening for latent Tuberculosis

infection (LTBI) prior to starting work. This is based on the

Mantoux skin test, which is notoriously unreliable.

In recent years, more specific and sensitive tests based on

interferon-gamma secretion to TB antigens have come to

market, and most current evidence shows that many

mantoux positive persons do not have LTBI. Quantiferon-

GOLD is one of these assays.

In this prospective study, we will draw blood for the

Quantiferon-GOLD assay in parallel to conventional testing,

and perform a cost-effectiveness analysis of the cost of the

investigation and treatment of LTBI in health-care workers.


Defined Population

Screening

Longitudinal

Blood test for Quantiferon-GOLD

assay

Israel

Sponsor: Assuta Hospital Systems

Collaborator: Maccabi

Inclusion Criteria:150 NCT00449345

Prospective Comparison of the

Tuberculin Skin Test and Interferon-

Gamma Release Assays in

Diagnosing Infection With

Mycobacterium Tuberculosis and in

Predicting Progression to

Tuberculosis

This is a prospective cohort study of persons tested for

latent tuberculosis infection at either high risk for exposure

to Mycobacterium tuberculosis or high risk for progression

to tuberculosis disease. The study will assess the relative

performance and cost of three diagnostic tests for latent

tuberculosis infection (tuberculin skin test, QuantiFERON-TB

Gold In-Tube, and T-SPOT.TB) and will examine the rates of

positive results among the cohort. This study will also

determine the risk and rate of progression to active TB

disease, overall and by the results of the three tests.



Observational Cohort

Prospective

Not provided USA

Sponsors and Collaborators

Centers for Disease Control and

Prevention

Individuals at high risk for

latent tuberculosis infection or

at high risk for progression to

tuberculosis

42647

NCT01622140

Study of Latent Tuberculosis

Infection (LTBI) by High Resolution

Scanner

The High Resolution Scanners (HR TC) offer the possibility of

detecting any lesion approximately 1 mm in diameter, so the

investigators plan to use this technique to screen people

already infected by M. tuberculosis (but not ill, following the

Diagnosis Standard Guidelines).



and biomarkers

Observational Case-Only

Prospective

Not provided Spain Sponsor:

Germans Trias i Pujol Hospital

Collaborator:

CIBERES CRP-TB program

Only a single population is

going to be studied: the LTBI,

thus people with proof to be

M. tuberculosis infected but

demonstrating not having

active disease.

12 NCT00904956

The Usefulness of Interferon-γ

Release Assays and Tuberculin Skin

Test for Detection of Latent


The purposes of this study

1.to compare the positivity of tuberculin skin test(TST) and

QuantiFERON-TB Gold (QFT-G), and determine the level of

agreement between two tests in patients with rheumatic

diseases

2.to evaluate the difference in the occurrence of active TB in

patients who receive both QFT-G and TST compared with

those who receive only TST for detecting of Latent

tuberculosis infection(LTBI) who are candidates of TNF

inhibitors.



Observational

Cohort

RetrospectiveNot provided

Korea, Republic of Sponsor:

Hanyang University

Collaborator:

Bristol-Myers Squibb

•Approximately 2,000 patients

with rheumatic diseases who

examined TST or QFT-G

•Approximately 400 patients

with rheumatic diseases who

received TST or QFT-G before

using anti-TNF agents.

2000 NCT01685905

A Phase I/II Trial of the

Pharmacokinetics, Tolerability, and

Safety of Once-Weekly Rifapentine

and Isoniazid in HIV-1-infected and

HIV-1-uninfected Pregnant and

Postpartum Women With Latent


The purpose of this study is to evaluate the

pharmacokinetics, tolerability, and safety of once-weekly

doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-

infected and HIV-1-uninfected pregnant and postpartum

women with latent tuberculosis (TB).

Treatment/pharmacokinetics

Interventional

Non-Randomized,

Pharmacokinetics Study,

Parallel Assignment,

Open Label

•Drug: Rifapentine (RPT)

900 mg of RPT

•Drug: Isoniazid (INH)

900 mg of INH

•Dietary Supplement: Pyridoxine

(vitamin B6)

Not provided Sponsor:



This study will enroll HIV-1-

infected and HIV-1-uninfected

pregnant women with latent

TB . Cohort 1 participants will

be enrolled in their second

trimester. Cohort 2

participants will be enrolled in

their third trimester

82 NCT02651259

•dietary supplement - world health organization · •dietary supplement: cholecalciferol...

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