Clinical trials: TB Infection
Pulmonary Tuberculosis
Clinical Trial of Phenylbutyrate and Vitamin D in Tuberculosis (TB)
Vitamin D exerts its effects via the Vitamin D Receptor (VDR) present in activated macrophages and induces expression and release of the cathelicidin, LL-37, a human antimicrobial peptide involved in killing of MTB.
- Trial name
- NCT01580007
- Testing
- Active Sodium Phenylbutyrate and active cholecalciferol
- Where
- Bangladesh
- Volunteers
- 288 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Tuberculosis, HIV
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)
Single-arm, multi-center, Phase I/II clinical trial, in two groups. Individuals with HIV infection taking Efavirenz (EFV), nevirapine (NVP) or lopinavir/ritonavir (LPV/r) and two nucleoside reverse transcriptase inhibitors (NRTI)…
- Trial name
- DOLPHIN KIDS (NCT05122767)
- Testing
- Dolutegravir, 3HP
- Where
- 2 sites in South Africa
- Volunteers
- 92 people
- Sponsor
- The Aurum Institute NPC
HIV Infections, Tuberculosis
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in South Africa
The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection.
- Trial name
- NCT00640887
- Testing
- rifabutin in combination with efavirenz, rifabutin in combination with nevirapine, rifabutin in combination with lopinavir/ritonavir
- Where
- South Africa
- Volunteers
- 48 people
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
Multi-drug Resistant Tuberculosis
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
- Trial name
- NCT03470233
- Where
- 2 sites in South Korea
- Volunteers
- 149 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Tuberculosis
A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV
This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.
- Trial name
- NCT00731471
- Testing
- MVA85A
- Where
- Senegal
- Volunteers
- 24 people
- Sponsor
- University of Oxford
Tuberculosis Infection, Tuberculosis Prevention
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts…
- Trial name
- NCT04494516
- Where
- 2 sites in Ethiopia, South Africa
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis
Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent.
- Trial name
- NCT03806699
- Testing
- ID93+GLA-SE
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Pulmonary Tuberculosis
Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB
Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB) Introduction: Tuberculosis (TB) places severe pressure on health care services of the developing world.
- Trial name
- ScreenTB (NCT03350048)
- Testing
- Trans-Dot point-of-care test
- Where
- 10 sites in Ethiopia, Germany and 6 more
- Volunteers
- 969 people
- Sponsor
- Prof Gerhard Walzl
Tuberculosis, Pulmonary
Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB
The development of efficacious, safe, and shorter treatment regimens could significantly improve TB management and treatment success rates.
- Trial name
- ESCAPE-TB (NCT04856644)
- Testing
- 4-month rifapentine-based regimen
- Where
- 4 sites in Taiwan
- Volunteers
- 333 people
- Sponsor
- Kaohsiung Veterans General Hospital.
Tuberculosis, Multidrug-Resistant
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis
Acquired drug-resistance is a major challenge for tuberculosis (TB) care programs. The 2020 WHO guidelines recommends replacing second-line injectables by bedaquiline in rifampicin-resistant TB (RR-TB) treatment regimens.
- Trial name
- Stake (NCT05555303)
- Testing
- Amikacin
- Where
- Rwanda
- Volunteers
- 20 people
- Sponsor
- Rwanda Biomedical Centre
Tuberculosis
Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.
This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose of 5 x 107pfu intradermally, is safe in…
- Trial name
- NCT00456183
- Testing
- MVA 85A
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis, Hiv
A One-stop Shop for the Same Day Diagnosis and Management of TB and HIV
TB is a major public health problem and the second most common cause of adult death due to infection in many low-income countries.
- Trial name
- NCT04043390
- Testing
- CRP and Molbio Truenat MTB, CRP and Xpert ULTRA MTB/RIF, standard test Xpert
- Where
- Nigeria
- Volunteers
- 1,100 people
- Sponsor
- Liverpool School of Tropical Medicine
Tuberculosis, Tuberculosis, Pulmonary
Feasibility of a Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in South Africa
The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Miliary
- Trial name
- NCT01693224
- Testing
- Alere "Determine" lateral-flow urine lipoarabinomannan assay, Alere "Clearview" ELISA urine LAM assay, Cepheid Xpert MTB/Rif assay
- Where
- 2 sites in South Africa
- Volunteers
- 512 people
- Sponsor
- Tuberculosis Clinical Diagnostics Research Consortium
Tuberculosis
Taima TB: 3HP Study
This phase IV clinical study trial will be conducted among persons who require treatment for LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario.
- Trial name
- NCT02689089
- Testing
- 3HP
- Where
- Canada
- Volunteers
- 182 people
- Sponsor
- Ottawa Hospital Research Institute
Pulmonary Tuberculosis
Improving Community Based Tuberculosis Care in Ethiopia
The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.
- Trial name
- community (NCT00803322)
- Where
- Ethiopia
- Volunteers
- 318 people
- Sponsor
- University of Bergen
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
Tuberculosis
The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis
The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.
- Trial name
- NCT00982969
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Armed Forces Capital Hospital, Republic of Korea
Tuberculosis, TPT
Systems Analysis and Improvement Approach to Prevent TB
This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape…
- Conditions
- Tuberculosis, TPT, TB - Tuberculosis
- Trial name
- SAIA-TB (NCT06314386)
- Testing
- Systems Analysis and Improvement Approach for TB (SAIA-TB)
- Where
- 16 sites in South Africa
- Volunteers
- 19,560 people
- Sponsor
- Boston College
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.
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
PRACTECAL-PKPD Sub Study
PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and…
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis
- Trial name
- PRACTECAL-PKPD (NCT04081077)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 5 sites in Belarus, South Africa
- Volunteers
- 240 people
- Sponsor
- Medecins Sans Frontieres, Netherlands