Clinical trials: Tuberculosis Prevention
HIV Infections, Tuberculosis
Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO)
The Temprano trial is based on the following assumptions: ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of severe HIV-related morbidity or death in the medium term.
- Trial name
- TEMPRANO (NCT00495651)
- Testing
- Antiretroviral medications, Antiretroviral medications+Isoniazid prophylaxis
- Where
- 9 sites in Côte d’Ivoire
- Volunteers
- 2,073 people
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
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
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Tuberculosis
Ultra Curto (Ultra Short) TB Prevention Therapy
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
- Trial name
- NCT04703075
- Testing
- Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg
- Where
- 2 sites in Brazil
- Volunteers
- 531 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Pulmonary
Digital Health Intervention to Improve TPT Uptake
Despite the evidence of the prevention and control measures of tuberculosis (TB), it still has an impact on the health, social, and economic aspects of the population.
- Trial name
- DHiTPT (NCT07313995)
- Testing
- Digital health intervention
- Where
- 14 sites in Ethiopia
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Arba Minch University
Pediatric HIV Infection, Tuberculosis Infection
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children.
- Trial name
- NCT05069688
- Testing
- rifampicin
- Where
- Nigeria
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Tuberculosis Infection, Isoniazid Adverse Reaction
Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.
- Trial name
- NCT05413551
- Testing
- Low-dose isoniazid, Standard dose of isoniazid, High-dose isoniazid
- Where
- Brazil
- Volunteers
- 78 people
- Sponsor
- Stanford University
Ototoxicity, Drug-Induced
Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy.
- Trial name
- NCT05730283
- Testing
- ORC-13661
- Where
- 8 sites in United States
- Volunteers
- 105 people
- Sponsor
- Kevin Winthrop
Adverse Reaction to Drug, 3HP
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction.
- Trial name
- NCT04655794
- Testing
- 3HP
- Where
- Taiwan
- Volunteers
- 500 people
- Sponsor
- Chang Gung Memorial Hospital
HIV Infections, Tuberculosis
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection
To evaluate the safety and effectiveness of a 6-month course of isoniazid ( INH ) in the prevention of clinical tuberculosis in anergic (having diminished or absent reactions to specific antigens) HIV-infected persons who are at…
- Trial name
- NCT00000959
- Testing
- Isoniazid, Pyridoxine hydrochloride
- Where
- 14 sites in United States
- Volunteers
- 600 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infertility, Female, Recurrent Implantation Failure
Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis
The purpose of this study is to assess the efficacy, safety and tolerability of the 1-month regimen of three times weekly rifapentine plus isoniazid in improving fertility outcome in recurrent implantation failure (RIF) patients…
- Conditions
- Infertility, Female, Recurrent Implantation Failure, Genital Tuberculoses, Female, Genital Tuberculosis, Latent
- Trial name
- SCRIPT-LGTB (NCT04528277)
- Testing
- rifapentine plus isoniazid
- Where
- China
- Volunteers
- 1,050 people
- Sponsor
- Huashan Hospital
Tuberculosis (TB), Human Immunodeficiency Virus (HIV) Prophylaxis
Integrating HIV Prevention With TB Household Contact Evaluation in Uganda
This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care…
- Trial name
- TB PrEP (NCT07119359)
- Testing
- Home-based HIV self-testing, Home-based initiation of PrEP
- Where
- Uganda
- Volunteers
- 2,480 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Pulmonology
The Safety, Completion Rate and Prevention Effect by Rifamycin-containing Regimens for Latent Tuberculosis Infection in Patients With Kidney Transplantation: a Prospective Intervention Pilot Study
Tuberculosis (TB) remains the leading infectious disease worldwide and kidney transplant recipients (KTR) is high risk population needing prevention from reactivation, which cause high mortality.
- Trial name
- NCT05588492
- Testing
- Rifamycin-containing regimen, Rifamycin-free regimen
- Where
- Taiwan
- Volunteers
- 500 people
- Sponsor
- National Taiwan University Hospital
Respiratory Tract Infections, HIV Infections
Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO)
Single-arm, single-center, Phase I/II clinical trial, in four groups. Individuals with HIV infection taking Efavirenz (EFV) and two nucleoside reverse transcriptase inhibitors (NRTI) who have undetectable (Groups 1 and 2) or…
- Trial name
- IMPAACT4TB (NCT03435146)
- Testing
- 3HP plus DTG +2NRTIs
- Where
- South Africa
- Volunteers
- 135 people
- Sponsor
- The Aurum Institute NPC
Tuberculosis
Community-based Tuberculosis Tracing and Preventive Therapy
The many gaps observed in the cascade of care of tuberculosis (TB) child contacts occur mostly in the screening, preventive therapy (PT) initiation and PT completion steps and the main drivers of these gaps are considered to be…
- Trial name
- CONTACT (NCT03832023)
- Testing
- Screening and initiating preventive therapy in communities
- Where
- 25 sites in Cameroon, Uganda
- Volunteers
- 1,400 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Silicosis, Tuberculosis
Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB.
- Trial name
- NCT02430259
- Testing
- Weekly INH / RRT given by DOT
- Where
- China
- Volunteers
- 566 people
- Sponsor
- Huashan Hospital
Diabetes Mellitus, Tuberculosis
Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus
Diabetes mellitus (DM) increases susceptibility to Tuberculosis (TB) and worsens TB patient outcomes. The number of patients with combined TB and DM now outnumbers that of combined TB and HIV and it has been estimated that 15-30%…
- Trial name
- PROTID (NCT04600167)
- Testing
- Isoniazid and Rifapentine (INH-RPT)
- Where
- 4 sites in Tanzania, Uganda
- Volunteers
- 3,000 people
- Sponsor
- Dr. Nyanda Elias Ntinginya
Post Tuberculosis
Mechanisms, Biomarkers and Pulmonary Rehabilitation in Post-TB Lung Disease
Tuberculosis (TB) affects millions of people worldwide, and many individuals continue to experience long-term health problems even after completing TB treatment.
- Trial name
- AFTER-TB (NCT07731009)
- Testing
- Pulmonary rehabilitation
- Volunteers
- 760 people
- Sponsor
- Jose Antonio Dominguez Benitez
Prevention of TB Recurrence
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo.
- Trial name
- NCT03152903
- Testing
- VPM1002 (Recombinant BCG Vaccine)
- Where
- 10 sites in Bangladesh, India
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.