Clinical trials: TB - Tuberculosis
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)
Pulmonary Tuberculosis
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive…
- Trial name
- NCT00567840
- Testing
- PA-824
- Where
- 2 sites in South Africa
- Volunteers
- 69 people
- Sponsor
- Global Alliance for TB Drug Development
Renal Impairment, Tuberculosis
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including…
- Trial name
- NCT03896750
- Testing
- PA-824
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Tuberculosis
Tuberculosis and Human Immunodeficiency Virus (HIV) Immune Reconstitution Syndrome Trial (THIRST)
The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess…
- Trial name
- THIRST (NCT00851630)
- Testing
- Fixed dose combination zidovudine/lamivudine/abacavir
- Where
- Tanzania
- Volunteers
- 70 people
- Sponsor
- Duke University
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
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 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
Covid19, Tuberculosis
New Reusable Mask Design With Superior Filtration and Fit
This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic.
- Conditions
- Covid19, Tuberculosis, Respiratory Viral Infection
- Trial name
- NCT04826809
- Testing
- N95 mask, Nordell single E-100 layer mask, Nordell double E-100 layer mask
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Latent Tuberculosis Infection, Tuberculosis
Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers
The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range.
- Trial name
- NCT00546273
- Testing
- RUTI
- Where
- 3 sites in Spain
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Germans Trias i Pujol Hospital
HIV, Tuberculosis
Sustainable East Africa Research in Community Health
The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach.
- Conditions
- HIV, Tuberculosis, Hypertension, Diabetes
- Trial name
- SEARCH (NCT01864603)
- Testing
- Universal ART in a streamlined care model, Annual Community Health Campaigns, Targeted PrEP and Targeted testing interventions
- Where
- 3 sites in Kenya, Uganda
- Volunteers
- 150,395 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Latent Tuberculosis Bacteriology and Histology Unknown, Latent Tuberculosis
A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease.
- Trial name
- NCT01865487
- Testing
- H56ug/IC31nmol
- Where
- 2 sites in South Africa
- Volunteers
- 98 people
- Sponsor
- Aeras
Pulmonary Tuberculosis
A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture…
- Trial name
- NCT02333799
- Testing
- Bedaquiline, PA-824, Linezolid
- Where
- 3 sites in South Africa
- Volunteers
- 109 people
- Sponsor
- Global Alliance for TB Drug Development
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
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative…
- Trial name
- NCT01424501
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- 6 sites in Estonia, Taiwan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
A Study of MVA85A in Healthy Infants
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection.
- Trial name
- NCT00953927
- Testing
- MVA85A/AERAS-485, Candida Skin Test Antigen
- Where
- 3 sites in South Africa
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
- Trial name
- NCT05203068
- Testing
- Recombinant tuberculosis allergen (RTA)
- Where
- Russia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and…
- Trial name
- NCT01215851
- Testing
- PA-824, Pyrazinamide, TMC207
- Where
- 2 sites in South Africa
- Volunteers
- 85 people
- Sponsor
- Global Alliance for TB Drug Development
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