Clinical trials: Infections, Human Immunodeficiency Virus and Tuberculosis, open to volunteers
HIV I Infection, Tuberculosis
Evaluating the Safety and Immunogenicity of MTBVAC
The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa
- Trial name
- HVTN605A5421 (NCT05947890)
- Testing
- MTBVAC, BCG
- Where
- 16 sites in South Africa
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
Tuberculosis
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Background: Most people with tuberculosis (TB) feel better after starting treatment. But for some people, the opposite happens. They may feel better at first, but then suddenly get worse. This is a paradoxical reaction.
- Trial name
- NCT04052022
- Where
- 3 sites in United States, Mexico
- Volunteers
- 140 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Sepsis, Tuberculosis
STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis
Sepsis, a life-threatening condition due to a dysregulated response to infection, is the leading cause of global mortality and is frequently driven by tuberculosis (TB) and drug-resistant bacteria in sub-Saharan Africa…
- Trial name
- STARS (NCT07332325)
- Testing
- Hydrocortisone administration, Expanded antimicrobial therapy
- Where
- 4 sites in Tanzania, Uganda
- Volunteers
- 344 people
- Sponsor
- University of Virginia
Multi Drug Resistant Tuberculosis, HIV Infections
An Adaptive Randomized Controlled Trial
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment…
- Trial name
- ADAP-TIV (NCT05633056)
- Testing
- Adherence support intevention
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Tuberculosis (TB), Tuberculosis Infection, Latent
Screening With Portable X-rays for Rapid Recognition of TB
SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a community-based tuberculosis (TB) screening strategy for migrant populations in New York City.
- Conditions
- Tuberculosis (TB), Tuberculosis Infection, Latent, HIV (Human Immunodeficiency Virus)
- Trial name
- SPOT-TB (NCT07737275)
- Testing
- Mobile chest radiography for tuberculosis screening
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
Tuberculosis
Evaluating Next Generation LAM Assays and Molecular Diagnostics (POC and Near POC) for the Diagnosis of TB Among People With Presumptive TB: a Prospective Multicentre Diagnostic Accuracy Study
This prospective multicentre study is planned to evaluate the next generation LAM assays and molecular diagnostics (POC and near POC) among people with presumptive Tuberculosis.
- Trial name
- DriveDx4TB (NCT06019052)
- Volunteers
- 1,890 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Drug Resistant Tuberculosis
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
The goal of the BringBPaL2Me Trial, a multi-principal investigator, multi-site, cluster randomized, non-inferiority trial is to compare nurse-led RR-TB treatment in primary care clinics to standard of care physician-led RR-TB…
- Trial name
- NCT05671718
- Testing
- Nurse-Led Treatment in Primary Care
- Where
- 5 sites in South Africa
- Volunteers
- 2,944 people
- Sponsor
- Johns Hopkins University
Tuberculosis, Tuberculosis (TB)
Questioning the Epidemiology of Asymptomatic TB
Tuberculosis (TB) remains one of the world's leading causes of morbidity and mortality. Current TB control strategies focus largely on the binary paradigm of TB, which tackle Mtb infection and the symptomatic stages of the…
- Conditions
- Tuberculosis, Tuberculosis (TB), HIV, HIV (Human Immunodeficiency Virus)
- Trial name
- TB QUEST (NCT07312266)
- Where
- Mozambique
- Volunteers
- 6,770 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
TB - Tuberculosis, HIV/AIDS
Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis
The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cause of death in the world.
- Trial name
- TB-LUNG (NCT04700579)
- Where
- 3 sites in South Africa
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch
Rifampin-resistant Tuberculosis, Drug-resistant Tuberculosis
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with…
- Trial name
- THERMOL (NCT06590428)
- Testing
- Therapeutic Drug Monitoring for Linezolid
- Where
- South Africa
- Volunteers
- 280 people
- Sponsor
- Albert Einstein College of Medicine
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, Pulmonary
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
This is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in…
- Trial name
- StatinTB (NCT04147286)
- Testing
- Atorvastatin 40mg
- Where
- South Africa
- Volunteers
- 220 people
- Sponsor
- University of Cape Town
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin.
- Trial name
- NCT07600775
- Testing
- MK-8527, Rifampin
- Volunteers
- 14 people
- Sponsor
- Merck Sharp & Dohme LLC
Tuberculosis, HIV
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice…
- Trial name
- DOVETAIL (NCT06497465)
- Testing
- Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO], Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
- Where
- 5 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Johns Hopkins University
Advanced HIV Disease
Advanced HIV Re-engagement in Care
Adults who are hospitalized in Lusaka, Zambia, and found to have advanced HIV disease will be enrolled and randomly assigned to receive the ARC intervention or standard of care.
- Trial name
- ARC (NCT07720128)
- Testing
- ARC
- Where
- Zambia
- Volunteers
- 724 people
- Sponsor
- University of Alabama at Birmingham
Tuberculosis, HIV
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without…
- Trial name
- TEACH (NCT05917210)
- Testing
- Peer-Navigaton TB-EC Strategy, Usual TB-EC Strategy
- Where
- Uganda
- Volunteers
- 1,920 people
- Sponsor
- Yale University
Tuberculosis, Child Health
The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-limited countries, at District…
- Conditions
- Tuberculosis, Child Health, HIV, Severe Acute Malnutrition
- Trial name
- DTB (NCT06593080)
- Testing
- The comprehensive TDA based approach
- Where
- 29 sites in Zambia
- Volunteers
- 30,240 people, healthy volunteers welcome
- Sponsor
- Chishala Chabala
HIV, Tuberculosis
Vicente Ferrer HIV Cohort Study
The VFHCS is a long-term prospective cohort study of HIV infected patients from a resource-poor rural setting in India. The aim of the study is to use data collected from routine clinical care in order to describe the…
- Conditions
- HIV, Tuberculosis, Cryptococcosis, Opportunistic Infections
- Trial name
- VFHCS (NCT02454569)
- Where
- India
- Volunteers
- 30,000 people
- Sponsor
- Rural Development Trust Hospital
Tuberculosis
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB).
- Trial name
- NCT07124559
- Testing
- Rifapentine, Isoniazid, Dolutegravir
- Where
- 11 sites in Botswana, Haiti and 4 more
- Volunteers
- 144 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Tuberculosis Infection, Latent
Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan
RIFA-REAL is a prospective observational longitudinal study evaluating the safety, feasibility, and effectiveness of rifapentine-based shorter treatment regimens for drug-susceptible tuberculosis (DS-TB) and tuberculosis…
- Conditions
- Tuberculosis, Tuberculosis Infection, Latent, Tuberculosis, Pulmonary, Drug Sensitive
- Trial name
- RIFA-REAL (NCT07668479)
- Volunteers
- 350 people
- Sponsor
- Public Union "Kazakhstan Association of Phthisiopulmonologists"