Clinical trials: TB
HIV Infections, Tuberculosis
Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income settings and can be a serious complication for HIV-infected pregnant women and their infants.
- Trial name
- NCT01494038
- Testing
- Isoniazid (INH)
- Where
- 13 sites in Botswana, Haiti and 6 more
- Volunteers
- 956 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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, 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, 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, Pulmonary
A Clinical Risk Score for Early Management of TB in Uganda
Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide…
- Trial name
- PredicTB (NCT05122624)
- Testing
- PredicTB score
- Where
- Uganda
- Volunteers
- 3,332 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
Latent Tuberculosis Infection
Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among…
- Trial name
- LTBI (NCT00804713)
- Testing
- BST, TST, QFT
- Where
- United States
- Volunteers
- 2,017 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Tuberculosis, Pulmonary
Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design
This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in…
- Trial name
- NCT01785186
- Testing
- SQ109, Rifampicin, Moxifloxacin
- Where
- 7 sites in South Africa, Tanzania
- Volunteers
- 365 people
- Sponsor
- Michael Hoelscher
Latent Tuberculosis Infection
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial.
- Trial name
- iAdhere (NCT01582711)
- Testing
- Self Administered Therapy (SAT), SMS reminders, isoniazid and rifapentine
- Where
- 12 sites in United States, China and 2 more
- Volunteers
- 1,002 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
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)
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, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
HIV Infections, Tuberculosis
Characteristics and Prevalence of Tuberculosis and HIV in Masiphumelele Township, Cape Town, South Africa
The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV.
- Trial name
- NCT00346476
- Where
- 2 sites in South Africa
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
Tuberculosis, HIV Infections
Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)
This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults.
- Trial name
- NCT01151189
- Testing
- MVA85A/AERAS-485
- Where
- 2 sites in Senegal, South Africa
- Volunteers
- 650 people
- Sponsor
- Aeras
Tuberculosis, HIV/AIDS
Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden
The overall objective of this study is to determine if a multi-component implementation intervention (SPIRIT) and additional leadership and management training that targets District Health Officers (DHOs) can increase IPT…
- Trial name
- SEARCH-IPT (NCT03315962)
- Testing
- SPIRIT Intervention
- Where
- Uganda
- Volunteers
- 163 people
- Sponsor
- University of California, San Francisco
Tuberculosis
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection
- Trial name
- DAR-PIA (NCT02712424)
- Testing
- DAR-901
- Where
- Tanzania
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center