Clinical trials: tuberculosis
Tuberculosis
A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB
This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity study in adults who have recently been successfully treated for drug-susceptible pulmonary Tuberculosis (TB).
- Trial name
- C-037-456 (NCT02375698)
- Testing
- H56:IC31
- Where
- 3 sites in South Africa
- Volunteers
- 22 people
- Sponsor
- Aeras
Tuberculosis
Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe
The study is designed to test the hypothesis that BCG administration via jet injector will produce a comparable immune response and that there will be no significant differences in safety or reactogenicity between BCG…
- Trial name
- NCT01742364
- Testing
- Bioject ID Pen, Needle and syringe
- Where
- South Africa
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- PATH
Obesity, Pharmacokinetics
Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations
This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight.
- Conditions
- Obesity, Pharmacokinetics, MRSA, Tuberculosis
- Trial name
- NCT01167452
- Testing
- Sulfamethoxazole/trimethoprim
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Tuberculosis, Tuberculosis, Pulmonary
Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda
In a previous randomized control trial, the investigators identified gaps in the implementation of tuberculosis (TB) contact investigation at multiple levels of the service delivery cascade.
- Trial name
- HCD-CoP (NCT05640648)
- Testing
- User-Centered Implementation Strategy, Standard Implementation Strategy
- Where
- Uganda
- Volunteers
- 10,477 people, healthy volunteers welcome
- Sponsor
- Yale University
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, Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00810407
- Testing
- rifabutin
- Volunteers
- 628 people
- Sponsor
- Pfizer
Pulmonary Tuberculosis
TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment
This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.
- Trial name
- NCT00694629
- Testing
- rifapentine, rifapentine 10 mg/kg, rifapentine 15 mg/kg
- Where
- 29 sites in United States, Brazil and 4 more
- Volunteers
- 334 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB).
- Trial name
- S31/A5349 (NCT02410772)
- Testing
- rifapentine, rifapentine and moxifloxacin, control
- Where
- 33 sites in United States, Brazil and 11 more
- Volunteers
- 2,516 people
- Sponsor
- Centers for Disease Control and Prevention
Recurrent Tuberculosis
Improving Retreatment Success (IMPRESS)
This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB, among patients previously treated for TB.
- Trial name
- IMPRESS (NCT02114684)
- Testing
- moxifloxacin
- Where
- South Africa
- Volunteers
- 197 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
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
Tuberculosis, Pulmonary
Optimization of the TB Treatment Regimen Cascade
Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion using vital staining reduces unfavorable outcome of Cat.
- Trial name
- OneRIF (NCT02153528)
- Testing
- double rimfampicin, Standard TB treatment
- Where
- Bangladesh
- Volunteers
- 701 people
- Sponsor
- Damien Foundation
Tuberculosis
Phase 1 Study of PBTZ169
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
- Trial name
- NCT03036163
- Testing
- PBTZ169 - 40 mg, PBTZ169 - 80 mg, PBTZ169 - 160 mg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- NCT03338621
- Testing
- Pretomanid, Bedaquiline, Moxifloxacin
- Where
- 26 sites in Brazil, Georgia and 6 more
- Volunteers
- 455 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Tuberculosis, Pulmonary
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy…
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory, Lung Diseases
- Trial name
- NCT04874948
- Testing
- 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043
- Where
- Netherlands
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
Tuberculosis
Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi
Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers.
- Trial name
- NCT02533089
- Testing
- KT intervention
- Where
- Malawi
- Volunteers
- 1,153 people
- Sponsor
- Dignitas International
Tuberculosis, Treatment Adherence
TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
The overall goal of this study is to conduct a Randomized Clinical Trial (RCT) to evaluate a tuberculosis treatment support tool (TB-TST), a cellular phone app developed using user-centered design principles and a paper-based…
- Trial name
- TB-TST (NCT04221789)
- Testing
- TB treatment assistant
- Where
- Argentina
- Volunteers
- 555 people
- Sponsor
- Institute for Clinical Effectiveness and Health Policy
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
Substance-Related Disorders, Mental Disorder
Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa
Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up…
- Conditions
- Substance-Related Disorders, Mental Disorder, Social Stigma, Depression
- Trial name
- Siyakhana (NCT05282173)
- Testing
- Siyakhana CHW Training
- Where
- South Africa
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Maryland, College Park
Tuberculosis, Pulmonary Tuberculosis
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard tuberculosis (TB) treatment regimen in adults with TB.
- Trial name
- NCT03882177
- Testing
- Pravastatin, Rifafour, Vitamin B6
- Where
- South Africa
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Tuberculosis
Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis
The investigators propose to conduct a phase 2 randomised (1:1) double-blind placebo-controlled trial of the dolutegravir-lamivudine-tenofovir fixed dose combination tablet daily with an additional 50 mg dose of…
- Trial name
- RADIANT-TB (NCT03851588)
- Testing
- Dolutegravir 50 mg
- Where
- South Africa
- Volunteers
- 108 people
- Sponsor
- University of Cape Town