Clinical trials: TB Infection
Tuberculosis
Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents
Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
- Trial name
- NCT02075203
- Testing
- AERAS-404, Bacillus Calmette-Guérin (BCG)
- Where
- 2 sites in South Africa
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Aeras
MDR-TB
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing.
- Trial name
- STREAM (NCT02409290)
- Testing
- Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine
- Where
- 13 sites in Ethiopia, Georgia and 5 more
- Volunteers
- 588 people
- Sponsor
- IUATLD, 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
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
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
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.
HIV Infection, Tuberculosis
Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB).
- Trial name
- STRIDE (NCT00108862)
- Testing
- Strategy: Immediate ART, Strategy: Deferred ART
- Where
- 26 sites in United States, Botswana and 11 more
- Volunteers
- 809 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tuberculosis, Pediatric
TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)
This evaluation will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and…
- Trial name
- TIPPI (NCT03948698)
- Testing
- Innovative approached to pediatric TB care
- Where
- 10 sites in Cameroon, Côte d’Ivoire and 8 more
- Volunteers
- 4,159,533 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Tuberculosis
Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
The purpose of this study is to compare three strategies for finding TB cases in a rural Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2) Conducting household contact investigations of…
- Trial name
- Kharitode TB (NCT02808507)
- Testing
- Active TB case finding
- Where
- 2 sites in South Africa
- Volunteers
- 4,852 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV Infection
REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment
People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away.
- Trial name
- REMEMBER (NCT01380080)
- Testing
- Atripla (r), Efavirenz, Truvada
- Where
- 18 sites in Brazil, Haiti and 8 more
- Volunteers
- 851 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tuberculosis
Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month…
- Trial name
- PREVENT TB (NCT00023452)
- Testing
- RPT + INH once weekly for 3 months given by DOT, Isoniazid (INH) daily for 9 months
- Where
- 26 sites in United States, Brazil and 2 more
- Volunteers
- 8,053 people
- Sponsor
- Centers for Disease Control and Prevention
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, 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
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
Hiv, Tuberculosis
Interrupting HIV and TB Stigma in the Household in Uganda
The investigators will carry out a prospective, household cluster-randomized, implementation trial evaluating a complex, multi-component, social and behavioral intervention designed to normalize the acceptance of HIV testing in…
- Conditions
- Hiv, Tuberculosis, Social Behavior, Stigma, Social
- Trial name
- NCT05124665
- Testing
- Social Support
- Where
- Uganda
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Yale University
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, 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
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, 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
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