Clinical trials: TB Infection
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, HIV/AIDS
Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden
The overall objective of this study is to determine if a multi-component implementation intervention (SPIRIT) and additional leadership and management training that targets District Health Officers (DHOs) can increase IPT…
- Trial name
- SEARCH-IPT (NCT03315962)
- Testing
- SPIRIT Intervention
- Where
- Uganda
- Volunteers
- 163 people
- Sponsor
- University of California, San Francisco
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
Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month…
- Trial name
- PREVENT TB (NCT00023452)
- Testing
- RPT + INH once weekly for 3 months given by DOT, Isoniazid (INH) daily for 9 months
- Where
- 26 sites in United States, Brazil and 2 more
- Volunteers
- 8,053 people
- Sponsor
- Centers for Disease Control and Prevention
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Hiv
Kharituwe TB Contact Tracing Study
The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations
- Trial name
- NCT04520113
- Testing
- Household contact tracing
- Where
- 2 sites in South Africa
- Volunteers
- 10,579 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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, Pulmonary
A Clinical Risk Score for Early Management of TB in Uganda
Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide…
- Trial name
- PredicTB (NCT05122624)
- Testing
- PredicTB score
- Where
- Uganda
- Volunteers
- 3,332 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- ZeNix (NCT03086486)
- Testing
- Pretomanid, Linezolid, Bedaquiline
- Where
- 11 sites in Georgia, Moldova and 2 more
- Volunteers
- 181 people
- Sponsor
- Global Alliance for TB Drug Development
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
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Trial of High-Dose Rifampin in Patients With TB
The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to shorten treatment for tuberculosis (TB) without causing more adverse events.
- Trial name
- HIRIF (NCT01408914)
- Testing
- Higher-Dose Rifampin
- Where
- 4 sites in United States, Peru and 1 more
- Volunteers
- 180 people
- Sponsor
- Harvard University Faculty of Medicine
Tuberculosis
Treatment of Latent TB Infection for Jailed Persons
The purpose of this study is to determine whether an alternative drug, (rifampin) given daily, is better at treating tuberculosis (TB) and more tolerable than the usual drug treatment, isoniazid (INH).
- Trial name
- NCT00128206
- Testing
- Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 364 people
- Sponsor
- University of California, San Francisco
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
Statin Adjunctive Therapy for TB
There is an urgent need for novel therapies to shorten TB treatment and improve long-term lung function outcomes. Host-directed therapies (HDT) have received significant attention recently given the ability of M.
- Trial name
- StAT-TB (NCT03456102)
- Testing
- Pravastatin
- Where
- South Africa
- Volunteers
- 16 people
- Sponsor
- Johns Hopkins University
Latent Tuberculosis Infection
Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV
Tuberculosis (TB) is the prototypical disease of poverty as it disproportionately affects marginalized and impoverished communities.
- Trial name
- 3HP-LTBI (NCT03702049)
- Testing
- Nurse-led Community Health Worker TBI (RN/CHW TBI) program
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, Irvine
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
Pulmonary TB, Pulmonary Tuberculosis
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult…
- Conditions
- Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
- Trial name
- NCT06058299
- Testing
- sorfequiline, Pretomanid, Linezolid
- Where
- 22 sites in Georgia, Philippines and 3 more
- Volunteers
- 309 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Pulmonary Tuberculosis
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
The METHOD study will examine whether adding metformin to standard antibiotic treatment for tuberculosis (TB) in people with HIV is safe and well tolerated.
- Conditions
- Tuberculosis, Pulmonary Tuberculosis, HIV Coinfection
- Trial name
- METHOD (NCT04930744)
- Testing
- Isoniazid, Rifampicin, Ethambutol
- Where
- 2 sites in South Africa
- Volunteers
- 112 people
- Sponsor
- University of Massachusetts, Worcester
Infections and Infestations, Pulmonary Tuberculosis
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose…
- Trial name
- DECODE (NCT04550832)
- Testing
- Delpazolid, Bedaquiline, Delamanid, Moxifloxacin
- Where
- 5 sites in South Africa, Tanzania
- Volunteers
- 76 people
- Sponsor
- LigaChem Biosciences, Inc.