Clinical trials: TB - Tuberculosis
Pulmonary Tuberculosis
Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed…
- Trial name
- NCT02465216
- Testing
- ID93 + GLA-SE
- Where
- 3 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Access to Advanced Health Institute (AAHI)
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Tuberculosis, Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00810407
- Testing
- rifabutin
- Volunteers
- 628 people
- Sponsor
- Pfizer
Pulmonary Tuberculosis
Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.
- Trial name
- NCT01498419
- Testing
- Moxifloxacin (M), Pretomid (Pa), Pyrazinamide (Z)
- Where
- 8 sites in South Africa, Tanzania
- Volunteers
- 207 people
- Sponsor
- Global Alliance for TB Drug Development
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
Pulmonary TB
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and…
- Trial name
- NCT03722472
- Testing
- ID93 + GLA-SE
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Latent Tuberculosis
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
This study explores primary care team members' knowledge, attitudinal, and skill gaps related to latent tuberculosis infection (LTBI) testing and treatment.
- Trial name
- NCT04188041
- Testing
- TB Infection ECHO
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Kent Hospital, Rhode Island
MDR-TB
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing.
- Trial name
- STREAM (NCT02409290)
- Testing
- Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine
- Where
- 13 sites in Ethiopia, Georgia and 5 more
- Volunteers
- 588 people
- Sponsor
- IUATLD, Inc
Tuberculosis
Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their TB…
- Trial name
- NCT01960257
- Testing
- Digital Health Feedback System, SOC DOT
- Where
- 2 sites in United States
- Volunteers
- 92 people
- Sponsor
- University of California, San Diego
Tuberculosis
Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule.
- Trial name
- NCT01669096
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test.
- Trial name
- NCT00621322
- Testing
- GSK Biologicals' AS01B adjuvant, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2
- Where
- Philippines
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infection, Tuberculosis
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV
There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor (PI)-based antiretroviral therapy (ART).
- Trial name
- NCT01601626
- Testing
- Standard-dose Lopinavir/Ritonavir, Double-dose Lopinavir/Ritonavir, Raltegravir
- Where
- 9 sites in Brazil, Haiti and 3 more
- Volunteers
- 71 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tuberculosis
Innovative Approach in Tuberculosis Care in Armenia
Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and…
- Trial name
- NCT02082340
- Testing
- TB knowledge and socio-psychological counseling session, SMS text messages, phone calls
- Where
- Armenia
- Volunteers
- 392 people
- Sponsor
- Varduhi Petrosyan
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
HIV, Tuberculosis
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
The investigators will study the efficacy of a novel cellular phone messaging system to communicate health information and facilitate early return to clinic after abnormal laboratory results in rural Uganda.
- Trial name
- NCT01579214
- Testing
- Cellular Phone Text Messages
- Where
- Uganda
- Volunteers
- 183 people
- Sponsor
- Massachusetts General Hospital
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus…
- Trial name
- NC-003 (NCT01691534)
- Testing
- TMC207 (J), PA-824 (PA), pyrazinamide (Z)
- Where
- 2 sites in South Africa
- Volunteers
- 105 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial…
- Trial name
- NCT05592223
- Testing
- BCG Vaccine USP, Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
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
Mycobacterium Infections, Nontuberculous
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary…
- Trial name
- OPTIMA (NCT03421743)
- Testing
- Inhaled molgramostim, Antimycobacterial regimen
- Where
- 5 sites in Australia, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Savara Inc.
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