Clinical trials: TB - Tuberculosis
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Tuberculosis, Meningeal
Adjunctive Linezolid for the Treatment of Tuberculous Meningitis
This is a phase II randomized open-label trial of high versus standard dose rifampin (RIF) with or without linezolid (LZD) for the first 4 weeks of treatment for Tuberculosis Meningitis (TBM) at Masaka Regional Referral Hospital…
- Trial name
- ALTER (NCT04021121)
- Testing
- LZD, High dose RIF, Standard dose RIF
- Where
- Uganda
- Volunteers
- 40 people
- Sponsor
- University of California, San Francisco
Tuberculosis
First Time in Human (FTIH) Safety and Pharmacokinetics (PK) Study of GSK3036656 in Healthy Subjects
GSK3036656 is being developed by GSK for the treatment of tuberculosis (TB). This is the FTIH study for GSK3036656 to evaluate the safety, tolerability and PK of single ascending and repeat oral doses of GSK3036656 in healthy…
- Trial name
- NCT03075410
- Testing
- GSK3036656
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Tuberculosis
Using Biomarkers to Predict TB Treatment Duration
Background: Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts about 6 months. Some people with less severe TB might not need to take the drugs that long.
- Trial name
- NCT02821832
- Testing
- Saliva collection, Urine collection, Sputum collection
- Where
- South Africa
- Volunteers
- 946 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, AIDS-related Complex
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
- Trial name
- NCT00201123
- Testing
- Aerosol Interferon-Gamma, Subcutaneous interferon-gamma
- Where
- 2 sites in United States, South Africa
- Volunteers
- 89 people
- Sponsor
- NYU Langone Health
Latent Tuberculosis Infection
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
The present study was to evaluate the usefulness of a whole-blood interferon-r release assays (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.
- Trial name
- NCT01007396
- Testing
- 1-step tuberculin skin test (TST) and blood sampling
- Where
- South Korea
- Volunteers
- 322 people
- Sponsor
- Samsung Medical Center
HIV/AIDS, Tuberculosis
Targeted Universal TB Testing With Simultaneous TPT Prescribing Among People Living With HIV in South Africa
Background: In 2023, the South African Department of Health introduced targeted universal TB testing (TUTT) at antiretroviral therapy (ART) initiation (irrespective of the presence of TB symptoms).
- Trial name
- TUTT-PT (NCT06739915)
- Testing
- TUTT-PT Intervention
- Where
- South Africa
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV-1 Infection, Tuberculosis
PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB
This study was done to evaluate the effect of HIV and TB treatment on a commonly used birth control method. It enrolled women who were infected with HIV and TB and were taking efavirenz (EFV; Sustiva®; an anti-HIV medication)…
- Trial name
- PRIDE-HT (NCT02412436)
- Testing
- Depot medroxyprogesterone acetate
- Where
- 5 sites in Botswana, Kenya and 2 more
- Volunteers
- 62 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tuberculosis
Ultra Curto (Ultra Short) TB Prevention Therapy
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
- Trial name
- NCT04703075
- Testing
- Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg
- Where
- 2 sites in Brazil
- Volunteers
- 531 people
- Sponsor
- Johns Hopkins University
Hiv, Tuberculosis
Interrupting HIV and TB Stigma in the Household in Uganda
The investigators will carry out a prospective, household cluster-randomized, implementation trial evaluating a complex, multi-component, social and behavioral intervention designed to normalize the acceptance of HIV testing in…
- Conditions
- Hiv, Tuberculosis, Social Behavior, Stigma, Social
- Trial name
- NCT05124665
- Testing
- Social Support
- Where
- Uganda
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Yale University
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
Pulmonary TB
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
- Trial name
- NCT03678688
- Testing
- 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832
- Where
- 3 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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, Pulmonary, Antibiotic Prophylaxis
Prevention of Tuberculosis in Prisons
The purpose of this study is to determine if the isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity of the disease.
- Trial name
- NCT03028129
- Testing
- Isoniazid 900 milligrams
- Where
- Brazil
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- Federal University of Mato Grosso
Tuberculosis
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background…
- Trial name
- NCT01131351
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 3 sites in Latvia, Lithuania
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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, 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, Latent Tuberculosis
Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)
The Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial) study will be a three-arm, open-label, parallel, randomized trial.
- Conditions
- Tuberculosis, Latent Tuberculosis, HIV/AIDS
- Trial name
- NCT03934931
- Testing
- Streamlined weekly DOT visits, Weekly DOT visit reminders, Cost reimbursement DOT
- Where
- Uganda
- Volunteers
- 1,656 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Tuberculosis
Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women
The purpose of this study was to evaluate the pharmacokinetics (PK), tolerability, and safety of once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with…
- Trial name
- NCT02651259
- Testing
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 5 sites in Haiti, Kenya and 3 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multidrug-Resistant
Treatment Shortening of MDR-TB Using Existing and New Drugs
The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen…
- Trial name
- MDR-END (NCT02619994)
- Testing
- Linezolid, Delamanid, Levofloxacin
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Seoul National University Hospital