Clinical trials: Tuberculosis Prevention
Tuberculosis, Hiv
A Pragmatic Randomised Study to Optimise Screening, Prevention and Care for Tuberculosis in Malawi
A pragmatic open, three-arm individually-randomised controlled trial and economic evaluation will be conducted in one primary health care centre in Blantyre, Malawi, where HIV and TB are major contributors to early mortality.
- Conditions
- Tuberculosis, Hiv, Tuberculosis, Pulmonary
- Trial name
- PROSPECT (NCT03519425)
- Testing
- Optimised HIV screening and linkage to care, Optimised tuberculosis screening and linkage to care
- Where
- Malawi
- Volunteers
- 1,455 people
- Sponsor
- Liverpool School of Tropical Medicine
Tuberculosis
Infant TB Infection Prevention Study
Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.
- Trial name
- iTIPS (NCT02613169)
- Testing
- Isoniazid
- Where
- Kenya
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Washington
Silicosis Tuberculosis
Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB.
- Trial name
- TB (NCT03900858)
- Testing
- Isoniazid；Rifapentine
- Where
- China
- Volunteers
- 566 people
- Sponsor
- Huashan Hospital
HIV Infections, Tuberculosis
Digital Health Promotion in Iringa, Tanzania
Increased health education has the potential to facilitate better use of health care services and to promote early treatment, thus it can strengthen the health care system, and ultimately reduce morbidity and mortality.
- Conditions
- HIV Infections, Tuberculosis, Cysticercosis, Tapeworm Pork
- Trial name
- NCT03808597
- Testing
- Digital health promotion intervention
- Where
- 6 sites in Tanzania
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Oslo
Tuberculosis
A Study of MVA85A in Healthy Infants
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection.
- Trial name
- NCT00953927
- Testing
- MVA85A/AERAS-485, Candida Skin Test Antigen
- Where
- 3 sites in South Africa
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infections, Tuberculosis
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with…
- Trial name
- NCT00000638
- Testing
- Isoniazid, Pyrazinamide, Pyridoxine hydrochloride
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 2,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Latent Tuberculosis
BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population
In the last decade, the incidence of tuberculosis (TB) has declined in much of the world, but has increased in Central and South America.
- Trial name
- PPT-BCG (NCT05541952)
- Testing
- BCG
- Where
- Brazil
- Volunteers
- healthy volunteers welcome
- Sponsor
- Federal University of Mato Grosso
Tuberculosis Prevention, HIV
Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and…
- Trial name
- NCT07628140
- Testing
- Differentiated service delivery (DSD) of TB preventive therapy (TPT)
- Where
- Kenya
- Volunteers
- 1,500 people
- Sponsor
- University of Washington
Tuberculosis
Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine
The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years
- Trial name
- NCT06873282
- Testing
- TB/Flu-05E
- Where
- 3 sites in Russia
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Research Institute of Influenza, Russia
Tuberculosis Infection, Household Contacts
Window Prophylaxis for Pediatric Tuberculosis Prevention Trial
The goal of this cluster-randomized controlled trial is to evaluate the effectiveness of tuberculosis preventive treatment (TPT) administered during the "window period" to prevent new Mycobacterium tuberculosis infections in…
- Conditions
- Tuberculosis Infection, Household Contacts, Children, Adolescent
- Trial name
- TB-WIN (NCT07086820)
- Testing
- Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks, Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks
- Where
- 13 sites in Chile
- Volunteers
- 647 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Tuberculosis, HIV I Infection
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB…
- Trial name
- ThiPhiSA (NCT06214910)
- Testing
- Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP), Clinic-link TPT
- Where
- South Africa
- Volunteers
- 301 people
- Sponsor
- University of Washington
Human Immunodeficiency Virus (HIV) Infection
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis
SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS)…
- Trial name
- SaDAPT (NCT05452616)
- Testing
- ART first- Therapeutic use trial, TB results first- Therapeutic use trial
- Where
- 2 sites in Lesotho, Malawi
- Volunteers
- 610 people
- Sponsor
- University Hospital, Basel, Switzerland
Tuberculosis Infection
Evaluation of ТВ/Flu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years
The aim of the study is to investigate safety, reactogenicity and immunogenicity of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years.
- Trial name
- NCT05945498
- Testing
- TB/Flu-05E vaccine
- Where
- Russia
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Tatyana Zubkova
Tuberculosis, Pulmonary, Antibiotic Prophylaxis
Prevention of Tuberculosis in Prisons
The purpose of this study is to determine if the isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity of the disease.
- Trial name
- NCT03028129
- Testing
- Isoniazid 900 milligrams
- Where
- Brazil
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- Federal University of Mato Grosso
Tuberculosis, Latent Tuberculosis
Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)
The Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial) study will be a three-arm, open-label, parallel, randomized trial.
- Conditions
- Tuberculosis, Latent Tuberculosis, HIV/AIDS
- Trial name
- NCT03934931
- Testing
- Streamlined weekly DOT visits, Weekly DOT visit reminders, Cost reimbursement DOT
- Where
- Uganda
- Volunteers
- 1,656 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Pediatric HIV Infection, Latent Tuberculosis
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children.
- Trial name
- NCT06281834
- Testing
- Rifapentine, Dolutegravir
- Where
- Nigeria
- Volunteers
- 25 people
- Sponsor
- Brigham and Women's Hospital
Tuberculosis, HIV/AIDS
TB Reduction Through ART and TB Screening Project
Tuberculosis (TB) has overtaken HIV as the leading infectious cause of death worldwide and requires a major policy shift for it to be controlled in line with the WHO Stop-TB goal to "end TB".
- Trial name
- TREATS (NCT03739736)
- Testing
- Combination of TB/HIV prevention activities (arm A), Combination of TB/HIV prevention activities (arm B), Standard of care (arm C)
- Where
- 2 sites in South Africa, Zambia
- Volunteers
- 4,200 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Tuberculosis (TB), Isoniazid Toxicity
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
Tuberculosis (TB) remains a significant public health concern in Thailand and globally, especially in tropical regions, with pulmonary TB being predominant. Besides affecting the lungs, TB can also impact extrapulmonary organs.
- Conditions
- Tuberculosis (TB), Isoniazid Toxicity, Rifampicin Toxicity, Pyrazinamide Adverse Reaction
- Trial name
- NCT06484530
- Testing
- N acetyl cysteine
- Where
- Thailand
- Volunteers
- 116 people
- Sponsor
- Mahidol University
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to…
- Trial name
- NCT05547464
- Testing
- BNT164a1, BNT164b1
- Where
- 8 sites in Mozambique, South Africa
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a…
- Trial name
- NCT05537038
- Testing
- BNT164a1, BNT164b1
- Where
- 3 sites in Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- BioNTech SE