Clinical trials: Tuberculosis, completed
HIV/AIDS, Tuberculosis
Prevent TB: Choice Architecture for TPT Delivery
Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what the investigators know works and what is actually delivered at the clinic-level…
- Trial name
- NCT04466488
- Testing
- Choice Architecture
- Where
- South Africa
- Volunteers
- 50,798 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis
Tuberculosis Treatment Shortening Trial
Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more…
- Trial name
- NCT00130247
- Testing
- Ethambutol, Isoniazid, Pyrazinamide
- Where
- 3 sites in Brazil, Philippines and 1 more
- Volunteers
- 394 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
MDR-TB, HIV
A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs.
- Trial name
- NCT02129244
- Testing
- NCM-Plus
- Where
- 15 sites in South Africa
- Volunteers
- 2,844 people
- Sponsor
- Johns Hopkins University
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, HIV I Infection
Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa
In sub-Saharan Africa, tuberculosis (TB) is the etiology of 25-50% of bloodstream infections (BSIs) and the leading cause of sepsis among people living with HIV.
- Conditions
- Tuberculosis, HIV I Infection, Sepsis
- Trial name
- ATLAS (NCT04618198)
- Testing
- Immediate anti-TB therapy, Sepsis-specific dose anti-TB therapy
- Where
- 2 sites in Tanzania, Uganda
- Volunteers
- 437 people
- Sponsor
- University of Virginia
Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis
BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once…
- Trial name
- NCT04044001
- Testing
- BTZ-043, Rifafour e-275®, Probe Drug Cocktail
- Where
- 2 sites in South Africa
- Volunteers
- 78 people
- Sponsor
- Michael Hoelscher
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, 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
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
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Pulmonary Tuberculosis
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
The METHOD study will examine whether adding metformin to standard antibiotic treatment for tuberculosis (TB) in people with HIV is safe and well tolerated.
- Conditions
- Tuberculosis, Pulmonary Tuberculosis, HIV Coinfection
- Trial name
- METHOD (NCT04930744)
- Testing
- Isoniazid, Rifampicin, Ethambutol
- Where
- 2 sites in South Africa
- Volunteers
- 112 people
- Sponsor
- University of Massachusetts, Worcester
Tuberculosis, HIV I Infection
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB…
- Trial name
- ThiPhiSA (NCT06214910)
- Testing
- Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP), Clinic-link TPT
- Where
- South Africa
- Volunteers
- 301 people
- Sponsor
- University of Washington
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
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
HIV-associated Tuberculosis
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis
A5406 hypothesized that dolutegravir (DTG) 50 mg taken twice daily provides adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated tuberculosis (TB).
- Trial name
- NCT05630872
- Testing
- Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC, 2HPZM
- Where
- 4 sites in South Africa, Thailand
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
Tuberculosis, HIV
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed…
- Trial name
- NCT02906007
- Testing
- Bedaquiline
- Where
- 4 sites in Haiti, South Africa
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Latent Tuberculosis
Brief Educational Video for Patients Prescribed LTBI Treatment
Many patients who are prescribed treatment for latent tuberculosis (LTBI) do not complete treatment. Effective interventions that are low-cost and feasible for large-scale implementation are needed to support efforts to eliminate…
- Trial name
- NCT05412212
- Testing
- LTBI video intervention
- Where
- United States
- Volunteers
- 1,894 people
- Sponsor
- Kaiser Permanente
Tuberculosis
TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection
Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three…
- Trial name
- NCT00164450
- Testing
- Isoniazid, Rifapentine
- Where
- 24 sites in United States, Brazil and 2 more
- Volunteers
- 158 people
- Sponsor
- Centers for Disease Control and Prevention
Multi-drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
- Trial name
- LiMiT (NCT00664313)
- Testing
- Linezolid
- Where
- South Africa
- Volunteers
- 36 people
- Sponsor
- Centers for Disease Control and Prevention