Clinical trials: TB - Tuberculosis
Tuberculosis
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane®…
- Trial name
- NCT01311505
- Testing
- Myrin© 2 (Rifampicin + Isoniazid), Rimactane® (Rifampicin)
- Where
- Philippines
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Multidrug-resistant Tuberculosis
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.
- Trial name
- NCT01424670
- Testing
- Delamanid + OBR
- Where
- 17 sites in Estonia, Latvia and 5 more
- Volunteers
- 511 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Drug-resistant Tuberculosis
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Adherence, Medication, Adherence, Patient
- Trial name
- NCT03266003
- Testing
- Electronic DOT, In-person DOT
- Where
- 4 sites in United States
- Volunteers
- 216 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- ZeNix (NCT03086486)
- Testing
- Pretomanid, Linezolid, Bedaquiline
- Where
- 11 sites in Georgia, Moldova and 2 more
- Volunteers
- 181 people
- Sponsor
- Global Alliance for TB Drug Development
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
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
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
- Trial name
- NC-005 (NCT02193776)
- Testing
- PA-824, bedaquiline, moxifloxacin
- Where
- 10 sites in South Africa, Tanzania and 1 more
- Volunteers
- 240 people
- Sponsor
- Global Alliance for TB Drug Development
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
Tuberculosis, Multidrug-Resistant, Tuberculosis
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or…
- Trial name
- NCT05382312
- Testing
- GSK3036656, Bedaquiline, Delamanid
- Where
- South Africa
- Volunteers
- 127 people
- Sponsor
- GlaxoSmithKline
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
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin
The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin.
- Trial name
- IMPACT-TB (NCT03891901)
- Testing
- Imatinib, Isoniazid, Rifabutin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Tuberculosis, Pulmonary
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults
Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.
- Trial name
- NCT03758612
- Testing
- TBI-223 oral suspension, TBI-223 enteric capsule, TBI-223 SR Tablet Prototype 1
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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
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
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In 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…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
HIV, Tuberculosis
Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study
The purpose of this study was to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) regimen for drug-susceptible (DS) tuberculosis (TB).
- Trial name
- NCT04311502
- Testing
- Rifapentine, Rifampicin, Isoniazid
- Where
- 6 sites in Haiti, India and 3 more
- Volunteers
- 104 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of log10 colony forming units (CFU) per ml sputum over the…
- Trial name
- NCT01215110
- Testing
- TMC207, Rifafour e-275 mg
- Where
- South Africa
- Volunteers
- 68 people
- Sponsor
- Global Alliance for TB Drug Development
HIV Coinfection, Aids/Hiv Problem
Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the…
- Conditions
- HIV Coinfection, Aids/Hiv Problem, Tuberculosis, Pulmonary, Human Immunodeficiency Virus
- Trial name
- MSPB_TB (NCT05065905)
- Testing
- Interferon-Gamma
- Where
- 2 sites in Russia
- Volunteers
- 78 people
- Sponsor
- SPP Pharmaclon Ltd.