Clinical trials: tuberculosis
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
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
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
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)
HIV Infections, Tuberculosis
Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB
People who are infected with HIV and tuberculosis (TB) need to receive medications that treat both diseases safely and effectively.
- Trial name
- NCT01751568
- Testing
- Raltegravir
- Where
- 4 sites in South Africa
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Pulmonary Tuberculosis
Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in Guangzhou
This is a prospective, randomized, parallel, controlled study comparing the efficacy and outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using pretreatment susceptibility tests in selection of…
- Trial name
- NCT01618422
- Testing
- Directly Observed Therapy (DOTS) plus, Directly Observed Therapy (DOTS)
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Chinese University of Hong Kong
HIV Infection, Tuberculosis
Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB).
- Trial name
- STRIDE (NCT00108862)
- Testing
- Strategy: Immediate ART, Strategy: Deferred ART
- Where
- 26 sites in United States, Botswana and 11 more
- Volunteers
- 809 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tuberculosis
The Impact of Vitamin D on Tuberculosis Among Koreans
Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this study is to elucidate the role of vitamin D deficiency in development and treatment outcomes among Korean TB patients.
- Trial name
- NCT01137370
- Where
- South Korea
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
HIV, Tuberculosis
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
- Trial name
- NCT04518228
- Testing
- Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA)
- Where
- 23 sites in United States, Brazil and 6 more
- Volunteers
- 205 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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, HIV I Infection
Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa
In sub-Saharan Africa, tuberculosis (TB) is the etiology of 25-50% of bloodstream infections (BSIs) and the leading cause of sepsis among people living with HIV.
- Conditions
- Tuberculosis, HIV I Infection, Sepsis
- Trial name
- ATLAS (NCT04618198)
- Testing
- Immediate anti-TB therapy, Sepsis-specific dose anti-TB therapy
- Where
- 2 sites in Tanzania, Uganda
- Volunteers
- 437 people
- Sponsor
- University of Virginia
Nontuberculous Mycobacterium Infection
A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection
The purpose of this study is to evaluate the efficacy and safety of open-label exposure of gNO in patients with NTM lung disease. Subjects will receive the study drug by inhaling through a nasal mask.
- Trial name
- NCT03748992
- Testing
- gNO
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Medical University of South Carolina
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.
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
Lung Tuberculosis, MDR TB
Tuberculosis Research of INA-RESPOND On Drug Resistance
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray…
- Trial name
- TRIPOD (NCT02758236)
- Testing
- No Intervention
- Where
- 7 sites in Indonesia
- Volunteers
- 490 people
- Sponsor
- Ina-Respond
Tuberculosis
Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis
Although effective therapy for tuberculosis is available, TB continues to cause significant problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise.
- Trial name
- NCT00728507
- Testing
- Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid, Isoniazid, Rifampin, Pyrazinamide, Ethambutol
- Where
- 3 sites in Brazil
- Volunteers
- 121 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Pediatric
TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)
This evaluation will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and…
- Trial name
- TIPPI (NCT03948698)
- Testing
- Innovative approached to pediatric TB care
- Where
- 10 sites in Cameroon, Côte d’Ivoire and 8 more
- Volunteers
- 4,159,533 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)