Clinical trials: Active Tuberculosis
Tuberculosis
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential.
- Trial name
- C-010-402 (NCT02414828)
- Testing
- AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp, AERAS-402 3 x 10^10 vp
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02256839
- Testing
- CST_001
- Where
- United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis, Tuberculosis, Pulmonary
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults
Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.
- Trial name
- NCT03758612
- Testing
- TBI-223 oral suspension, TBI-223 enteric capsule, TBI-223 SR Tablet Prototype 1
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Pretomanid in Adults With Hepatic Impairment
This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects.
- Trial name
- NCT02422524
- Testing
- PA-824
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis, Bronchiectasis Adult
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.
- Conditions
- Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
- Trial name
- NCT04884308
- Testing
- BCG TICE Vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Obesity, Leprosy
Effect of Weight and/or Obesity on Dapsone Drug Concentrations
This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.
- Conditions
- Obesity, Leprosy, Tuberculosis
- Trial name
- NCT01165840
- Testing
- Dapsone
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Substance-Related Disorders, Mental Disorder
Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa
Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up…
- Conditions
- Substance-Related Disorders, Mental Disorder, Social Stigma, Depression
- Trial name
- Siyakhana (NCT05282173)
- Testing
- Siyakhana CHW Training
- Where
- South Africa
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Maryland, College Park
Tuberculosis
Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults
This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.
- Trial name
- NCT00397943
- Testing
- GSK's candidate Mycobacterium tuberculosis vaccine 692342, Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system, Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline
- Where
- Belgium
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection
- Trial name
- DAR-PIA (NCT02712424)
- Testing
- DAR-901
- Where
- Tanzania
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
Tuberculosis, Tuberculosis, Pulmonary
Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda
In a previous randomized control trial, the investigators identified gaps in the implementation of tuberculosis (TB) contact investigation at multiple levels of the service delivery cascade.
- Trial name
- HCD-CoP (NCT05640648)
- Testing
- User-Centered Implementation Strategy, Standard Implementation Strategy
- Where
- Uganda
- Volunteers
- 10,477 people, healthy volunteers welcome
- Sponsor
- Yale University
Latent Tuberculosis, Human Immunodeficiency Virus
Doravirine, Rifapentine and Isoniazid Interaction
Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex.
- Conditions
- Latent Tuberculosis, Human Immunodeficiency Virus, Rifamycins Causing Adverse Effects in Therapeutic Use, Drug Interaction Potentiation
- Trial name
- DORIIS (NCT03886701)
- Testing
- Doravirine (DOR), Rifapentine (RPT), Isoniazid (INH)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Walter K. Kraft
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, Iron Deficiency Anemia
Universal Screening for Tuberculosis and Anemia With the CHICA System
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians.
- Trial name
- NCT01322841
- Testing
- CHICA Diagnosis Module
- Where
- United States
- Volunteers
- 2,239 people, healthy volunteers welcome
- Sponsor
- Indiana University
Latent Tuberculosis Infection, Tuberculosis
Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers
The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range.
- Trial name
- NCT00546273
- Testing
- RUTI
- Where
- 3 sites in Spain
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Germans Trias i Pujol Hospital
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative…
- Trial name
- NCT01424501
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- 6 sites in Estonia, Taiwan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis, Tuberculosis, Pulmonary
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy…
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory, Lung Diseases
- Trial name
- NCT04874948
- Testing
- 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043
- Where
- Netherlands
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
Tuberculosis
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus…
- Trial name
- NCT04152161
- Testing
- BCG vaccine SSI
- Where
- 5 sites in South Africa
- Volunteers
- 1,836 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Tuberculosis, Pulmonary, Rifampicin Resistant Tuberculosis
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing.
- Trial name
- XPEL-TB (NCT03044158)
- Testing
- GeneXpert I, Process re-design, Performance Feedback
- Where
- 20 sites in Uganda
- Volunteers
- 10,644 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Tuberculosis
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin
The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin.
- Trial name
- IMPACT-TB (NCT03891901)
- Testing
- Imatinib, Isoniazid, Rifabutin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Tuberculosis
Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa
The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa.
- Trial name
- NCT00096681
- Volunteers
- 762 people, healthy volunteers welcome
- Sponsor
- CIPRA SA