Clinical trials: Mycobacterium Infections
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
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Human Immunodeficiency Virus
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV
The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).
- Trial name
- MESA-TB (NCT04556981)
- Testing
- M72/AS01E Mycobacterium tuberculosis vaccine
- Where
- 6 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Gates Medical Research Institute
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
Tuberculosis
A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB
This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity study in adults who have recently been successfully treated for drug-susceptible pulmonary Tuberculosis (TB).
- Trial name
- C-037-456 (NCT02375698)
- Testing
- H56:IC31
- Where
- 3 sites in South Africa
- Volunteers
- 22 people
- Sponsor
- Aeras
HIV/AIDS, Tuberculosis
Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons with HIV as TB is the leading cause of death among persons with HIV worldwide.
- Trial name
- DIPT (NCT03492216)
- Testing
- Incentives for negative EtG test, Incentives for positive IsoScreen test
- Where
- 2 sites in Uganda
- Volunteers
- 680 people
- Sponsor
- University of California, San Francisco
Leprosy
Leprosy Skin Test Antigens Trial
The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to…
- Trial name
- NCT00128193
- Testing
- Tuberculin, Purified Protein Derivative, MLSA-LAM, MLCwA
- Where
- 6 sites in United States, Nepal
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Isoniazid (INH) is a drug commonly used to treat tuberculosis (TB) worldwide. Sometimes, the bacteria that cause TB can become resistant to INH.
- Trial name
- NCT01936831
- Testing
- Isoniazid, Vitamin B6
- Where
- 2 sites in Haiti, South Africa
- Volunteers
- 282 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tuberculosis, Treatment Adherence
TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
The overall goal of this study is to conduct a Randomized Clinical Trial (RCT) to evaluate a tuberculosis treatment support tool (TB-TST), a cellular phone app developed using user-centered design principles and a paper-based…
- Trial name
- TB-TST (NCT04221789)
- Testing
- TB treatment assistant
- Where
- Argentina
- Volunteers
- 555 people
- Sponsor
- Institute for Clinical Effectiveness and Health Policy
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
Study of Daily Rifapentine for Pulmonary Tuberculosis
The goal of this Phase 2 study is to determine the microbiological activity and safety of rifapentine when given as a component of multidrug intensive phase treatment of smear-positive pulmonary tuberculosis (TB).
- Trial name
- NCT00814671
- Testing
- Rifapentine 450, Rifapentine 600, Rifampin
- Where
- South Africa
- Volunteers
- 153 people
- Sponsor
- Johns Hopkins University
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
HIV/AIDS, Tuberculosis, Pulmonary
INSTI's For The Management of HIV-associated TB
This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected…
- Trial name
- INSIGHT (NCT04734652)
- Testing
- Biktarvy®, TLD- fixed-drug combination single tablet
- Where
- South Africa
- Volunteers
- 122 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
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
Tuberculosis, HIV Infections
Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10^10 vp (N=13) or placebo…
- Trial name
- NCT01017536
- Testing
- AERAS-402
- Where
- South Africa
- Volunteers
- 26 people
- Sponsor
- Aeras
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
Tuberculosis
Essentiality of INH in TB Therapy
Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs.
- Trial name
- NCT01589497
- Testing
- Rifampicin, Isoniazid, Pyrazinamide
- Where
- 2 sites in South Africa
- Volunteers
- 69 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections