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Tuberculosis clinical trials

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NCT ID: NCT05124678 Recruiting - Tuberculosis Clinical Trials

Pharmacogenetics-guided Isoniazid Dosing in TB-HIV

PHINX
Start date: December 7, 2021
Phase: Phase 2
Study type: Interventional

The current TB treatment as recommended by World Health Organization (WHO) although capable of achieving 85% cure rates, has limitations, in particular drug interactions, toxicities, and the long treatment duration which increases the possibility of nonadherence. Sub-therapeutic isoniazid concentrations were demonstrated in several studies, including our previous work, carried out among patients with tuberculosis receiving the standard dose (5mg/kg) of isoniazid. The investigators found 78% of patients with HIV had isoniazid concentrations below the recommended threshold. Malabsorption, drug-drug interactions, poor adherence due to high pill burden may contribute to this. Pharmacogenetic variation may compound these factors; isoniazid displays inter-individual variation in serum concentrations and clearance due to differences in individual acetylator status. While patients who metabolize isoniazid slowly (slow acetylators) are at a higher risk of high drug concentrations and toxicities, fast acetylators are more likely to have sub-therapeutic isoniazid concentrations. In other studies, insufficient exposure with isoniazid, one of the cornerstone drugs for TB treatment, has been associated with delayed sputum clearance, development of drug resistance, and treatment failure. Isoniazid is metabolized by the enzyme N-acetyl transferase, which in turn is controlled by the N-acetyl transferase-2 (NAT-2) gene. Polymorphisms in this gene are responsible for the N-acetylation phenotypes, with the distribution of NAT-2 fast, intermediate, and slow acetylators being highly variable especially among African populations. Given that NAT2 acetylator status explains most of the variability in INH exposures, knowledge of NAT2 status may be a simpler way to select the right dose for individual patients. The investigators will therefore provide higher doses to fast acetylators and compare the isoniazid pharmacokinetics in these patients to slow acetylators who receive the standard dose, who are more likely to already be achieving target concentrations.

NCT ID: NCT05124665 Completed - Hiv Clinical Trials

Interrupting HIV and TB Stigma in the Household in Uganda

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

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 the household and increase diagnosis of HIV.

NCT ID: NCT05122767 Recruiting - HIV Clinical Trials

Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)

DOLPHIN KIDS
Start date: May 24, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Single-arm, multi-center, Phase I/II clinical trial, in two groups. Individuals with HIV infection taking Efavirenz (EFV), nevirapine (NVP) or lopinavir/ritonavir (LPV/r) and two nucleoside reverse transcriptase inhibitors (NRTI) who have undetectable HIV viral load (VL) (< 50 copies/mL) and an indication for tuberculosis (TB) preventive treatment (TPT), will be switched to dolutegravir (DTG) with tenofovir/emtricitabine (TDF/FTC), tenofovir/lamivudine (TDF/3TC), abacavir/lamivudine (ABC/3TC) or zidovudine/lamivudine (AZT/3TC) in accordance with South African National HIV Guidelines. Groups 1 and 2 will receive weekly HP for 12 total doses starting 4 weeks after initiating DTG. Individuals who are on an existing DTG-based plus two NRTI antiretroviral therapy (ART) regimen for at least four weeks (and have not received efavirenz, or nevirapine or lopinavir/ritonavir for at least four weeks) who have an undetectable HIV viral load may also participate.

NCT ID: NCT05122624 Completed - Clinical trials for Tuberculosis, Pulmonary

A Clinical Risk Score for Early Management of TB in Uganda

PredicTB
Start date: November 10, 2021
Phase: N/A
Study type: Interventional

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 same-day diagnostic testing. The research team has developed an easy-to-use clinical risk score that, if implemented in these settings, might help clinicians identify patients at high risk for TB and thereby start treatment for those patients on the same day. This study will investigate the effectiveness and implementation of this score in four peri-urban clinics in Uganda, providing critical pragmatic data to inform (or halt) the design of a definitive large-scale cluster randomized trial.

NCT ID: NCT05122026 Recruiting - Pregnancy Clinical Trials

Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV

DOLPHIN Moms
Start date: January 17, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, and pharmacokinetics (PK), and potential interactions between dolutegravir (DTG) and rifapentine (RPT) during pregnancy in people with HIV when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) or weekly for 3 months (3HP) as part of tuberculosis (TB) preventive therapy (TPT). Adults (age ≥18) who are pregnant with a singleton pregnancy (confirmed by ultrasound) at a gestational age of 20-34 weeks and virally suppressed on an existing DTG-based plus two nucleoside reverse transcriptase inhibitors (NRTI) antiretroviral (ART) regimen for at least four weeks may participate.

NCT ID: NCT05118490 Recruiting - Tuberculosis Clinical Trials

Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients

1 to 3
Start date: July 19, 2023
Phase: Phase 4
Study type: Interventional

A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.

NCT ID: NCT05117788 Active, not recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Bioneer IRONqPCR ™ RFIA Kit Kit Clinical Evaluation

Start date: February 23, 2022
Phase:
Study type: Observational

Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer IRONqPCR ™ RFIA Kit is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed tests that can identify resistance to both first and second-line drugs in one reaction.

NCT ID: NCT05116098 Not yet recruiting - Tuberculosis Clinical Trials

Randomized Clinical Trial: IS Zinc and Zinc Ionophere EGCG as Supplement Improve Outcome of Active Pulmonary Tuberculosis

Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

Tuberculosis is still global burden disease at all the word and effect on quality life of patients and affect on health authorities because the cost of medicine and health cost . - A total of 1.4 million people died from TB in 2019 (including 208 000 people with HIV). Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS). - In 2019, an estimated 10 million people fell ill with tuberculosis (TB) worldwide. 5.6 million men, 3.2 million women and 1.2 million children. TB is present in all countries and age groups. But TB is curable and preventable. - In 2019, 1.2 million children fell ill with TB globally. Child and adolescent TB is often overlooked by health providers and can be difficult to diagnose and treat. - In 2019, the 30 high TB burden countries accounted for 87% of new TB cases. Eight countries account for two thirds of the total, with India leading the count, followed by Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa. ( WHO) All TB cases and 92.5% controls were zinc deficient. The odds of TB cases with deficiencies of vitamin A and zinc was 2.3 (95% CI: 1.1 to 4.8) times more likely as compared to the controls. More than 80% of all participants had below average fulfilment of energy and vitamin A intakes. (7) Zinc is necessary for intact immune health and defense against infection but there are common health problem deficiency at developing countries and so zinc needs as supplement and the second problem zinc need helper for transfer through plasma membrane so zinc ionophore is a best solution as this problem so the investigators can use zinc ionophore as helper for zinc to enter the cells for autophagy

NCT ID: NCT05110950 Not yet recruiting - Lymphoma Clinical Trials

Endobronchial Ultrasound Needle Aspiration With and Without Suction

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The main purpose of the present study is to compare the diagnostic yield of different aspiration techniques in Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) in the diagnosis of hilar/mediastinal adenopathy

NCT ID: NCT05100758 Completed - Tuberculosis Clinical Trials

Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Background Active Hexose Correlated Compound is assumed to have a positive effect on immunity, including induce a phagocytic response, reduce tumor resistance, and cytokine response including interferon-gamma and interleukins. Tuberculosis patients with concurrent Human immunodeficiency Virus (HIV) might have benefit when receiving active hexose compound during tuberculosis treatment Purposes 1. To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV 2. To assess the difference of pro-inflammatory cytokines between standard therapy and active hexose compound adjuvant Methods A clinical trial involving patients with Tuberculosis-HIV infection Hypothesis 1. Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome 2. Lower proinflammatory cytokines are observed in people who receive active compound