Clinical trials: Mycobacterium Infection
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
HIV/AIDS, Tuberculosis, Pulmonary
INSTI's For The Management of HIV-associated TB
This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected…
- Trial name
- INSIGHT (NCT04734652)
- Testing
- Biktarvy®, TLD- fixed-drug combination single tablet
- Where
- South Africa
- Volunteers
- 122 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Obesity, Tuberculosis
Effect of Weight and/or Obesity on Ethambutol Drug Concentrations
This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol.
- Trial name
- NCT01048697
- Testing
- Ethambutol
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Crohn Disease
Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease
An open label extension to the RHB-104-01 Study.
- Trial name
- MAPUS2 (NCT03009396)
- Testing
- RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 54 people
- Sponsor
- RedHill Biopharma Limited
Latent Tuberculosis
Tuberculosis Clinical Trials Consortium Study 35
Hypotheses: Rifapentine (given as water-dispersible monolayer and/or fixed dose combination with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent TB infection (LTBI) or with exposure to…
- Trial name
- NCT03730181
- Testing
- Rifapentine, Isoniazid
- Where
- South Africa
- Volunteers
- 69 people
- Sponsor
- Centers for Disease Control and Prevention
Mycobacterium Infections, Nontuberculous
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease.
- Trial name
- NCT01315236
- Testing
- Liposomal amikacin for inhalation (LAI)
- Where
- 19 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Insmed Incorporated
Tuberculosis
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02142894
- Testing
- CST001
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- QIAGEN Gaithersburg, Inc
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
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential.
- Trial name
- C-010-402 (NCT02414828)
- Testing
- AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp, AERAS-402 3 x 10^10 vp
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Choose healthy subjects and patients with TB, distribute them into different dose groups according to the recombinant EC allergen dose from low to high average.
- Trial name
- NCT02329730
- Testing
- 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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
Tuberculosis
Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis
The Tuberculosis Trials Consortium (TBTC) Study 31 is a phase 3 trial evaluating rifapentine-containing regimens for treatment-shortening of drug-susceptible pulmonary tuberculosis.
- Trial name
- S31PK/PD (NCT02563327)
- Testing
- Rifapentine, Moxifloxacin, Rifampin
- Where
- 3 sites in United States, Uganda and 1 more
- Volunteers
- 2,516 people
- Sponsor
- Centers for Disease Control and Prevention
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
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)
Leprosy
Leprosy Skin Test Antigens Trial
The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to…
- Trial name
- NCT00128193
- Testing
- Tuberculin, Purified Protein Derivative, MLSA-LAM, MLCwA
- Where
- 6 sites in United States, Nepal
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Infection, Human Immunodeficiency Virus, HIV Infections
Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection
HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide.
- Trial name
- NCT02178592
- Testing
- DTG 50 mg, EFV 600 mg
- Where
- 28 sites in Argentina, Brazil and 5 more
- Volunteers
- 113 people
- Sponsor
- ViiV Healthcare
Tuberculosis, Tuberculosis Vaccines
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo.
- Trial name
- NCT01755598
- Testing
- GSK Biologicals' investigational TB vaccine (GSK692342)
- Where
- 9 sites in Kenya, South Africa and 1 more
- Volunteers
- 3,575 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
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