Clinical trials: Tuberculosis Prevention
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Post Tuberculosis
Mechanisms, Biomarkers and Pulmonary Rehabilitation in Post-TB Lung Disease
Tuberculosis (TB) affects millions of people worldwide, and many individuals continue to experience long-term health problems even after completing TB treatment.
- Trial name
- AFTER-TB (NCT07731009)
- Testing
- Pulmonary rehabilitation
- Volunteers
- 760 people
- Sponsor
- Jose Antonio Dominguez Benitez
Tuberculosis
Ultra Curto (Ultra Short) TB Prevention Therapy
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
- Trial name
- NCT04703075
- Testing
- Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg
- Where
- 2 sites in Brazil
- Volunteers
- 531 people
- Sponsor
- Johns Hopkins University
Tuberculosis Infection, Tuberculosis Prevention
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts…
- Trial name
- NCT04494516
- Where
- 2 sites in Ethiopia, South Africa
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis
Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents
Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
- Trial name
- NCT02075203
- Testing
- AERAS-404, Bacillus Calmette-Guérin (BCG)
- Where
- 2 sites in South Africa
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Aeras
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
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
Respiratory Tract Infections, HIV Infections
Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO)
Single-arm, single-center, Phase I/II clinical trial, in four groups. Individuals with HIV infection taking Efavirenz (EFV) and two nucleoside reverse transcriptase inhibitors (NRTI) who have undetectable (Groups 1 and 2) or…
- Trial name
- IMPAACT4TB (NCT03435146)
- Testing
- 3HP plus DTG +2NRTIs
- Where
- South Africa
- Volunteers
- 135 people
- Sponsor
- The Aurum Institute NPC
Lung Diseases, Tuberculosis
Tuberculosis Prophylaxis in the Homeless--A Controlled Trial
To conduct a three-arm, randomized controlled trial of methods to improve adherence to biweekly directly observed prophylaxis (DOPT) for tuberculosis in homeless adults in San Francisco.
- Trial name
- NCT00005737
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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
Tuberculosis, HIV Infections
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety…
- Trial name
- NCT01404312
- Testing
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6)
- Where
- 45 sites in United States, Botswana and 8 more
- Volunteers
- 3,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Seropositivity, Pregnancy
Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV
Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, and pharmacokinetics (PK), and potential interactions between dolutegravir (DTG) and rifapentine (RPT) during pregnancy in people with HIV…
- Conditions
- HIV Seropositivity, Pregnancy, Tuberculosis Infection
- Trial name
- DOLPHIN Moms (NCT05122026)
- Testing
- Rifapentine, Isoniazid
- Where
- 3 sites in South Africa
- Volunteers
- 252 people
- Sponsor
- The Aurum Institute NPC
Prevention of TB Recurrence
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo.
- Trial name
- NCT03152903
- Testing
- VPM1002 (Recombinant BCG Vaccine)
- Where
- 10 sites in Bangladesh, India
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
HIV Infections, Tuberculosis
Tuberculosis Prevention for HIV Infected Adults
This study compares three different tuberculosis (TB) prevention regimens against the standard regimen of 6 months of isoniazid. It is being conducted in Soweto, South Africa.
- Trial name
- NCT00057122
- Testing
- Isoniazid, Rifapentine, Rifampin
- Where
- South Africa
- Volunteers
- 1,148 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Children LTBI
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
The management of latent Mycobacterium tuberculosis infection is a new priority action for the WHO End Tuberculosis (TB) Strategy.
- Trial name
- NCT04156568
- Testing
- INH、RFT
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Beijing Children's Hospital
Tuberculosis, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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, Pulmonary
Study to Evaluate H56:IC31 in Preventing Rate of TB Recurrence
This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups. H56:IC31 (investigational vaccine) Placebo 900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are…
- Trial name
- NCT03512249
- Testing
- H56:IC31
- Where
- 6 sites in South Africa, Tanzania
- Volunteers
- 831 people
- Sponsor
- International AIDS Vaccine Initiative
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