Clinical trials: Infections, Human Immunodeficiency Virus and Tuberculosis
HIV Infections, Tuberculosis
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with…
- Trial name
- NCT00000638
- Testing
- Isoniazid, Pyrazinamide, Pyridoxine hydrochloride
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 2,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, HIV
Evaluation of the Effect of 3HP vs Periodic 3HP vs 6H in HIV-Positive Individuals
This study is a parallel, two part, open label, individually randomized, pragmatic trial among HIV-positive individuals. Part A compares a single round of weekly high dose rifapentine plus isoniazid for three months (3HP) to six…
- Trial name
- WHIP3TB (NCT02980016)
- Testing
- rifapentine + isoniazid, Isoniazid
- Where
- South Africa
- Volunteers
- 4,027 people, healthy volunteers welcome
- Sponsor
- The Aurum Institute NPC
HIV Infections
TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)
The purpose of this Phase I, open-label, single sequence drug-drug interaction trial in human immunodeficiency virus-type 1 infected patients is to investigate the potential interaction between steady-state nevirapine (NVP) 200…
- Trial name
- NCT00910806
- Testing
- TMC207; nevirapine
- Where
- South Africa
- Volunteers
- 16 people
- Sponsor
- Tibotec BVBA
HIV/AIDS
Swaziland HIV Incidence Measurement Survey 2
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators.
- Trial name
- SHIMS2 (NCT04117984)
- Where
- Eswatini
- Volunteers
- 15,429 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
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)
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
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
AIDS-Related Opportunistic Infections, Meningo-encephalitis
Driving Reduced AIDS-associated Meningo-encephalitis Mortality
The DREAMM project is investigating whether the DREAMM interventions (1) Health system strengthening, 2) Co-designed education programs tailored to frontline healthcare workers, 3) Implementation of a diagnostic and treatment…
- Conditions
- AIDS-Related Opportunistic Infections, Meningo-encephalitis, Cryptococcal Meningitis, Bacterial Meningitis
- Trial name
- DREAMM (NCT03226379)
- Testing
- DREAMM
- Where
- 5 sites in Cameroon, Malawi and 1 more
- Volunteers
- 495 people
- Sponsor
- St George's, University of London
Tuberculosis, Hiv
A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects
This is a single-center, open-label, fixed sequence, pharmacokinetic interaction study between bictegravir and tenofovir alafenamide with rifapentine dosed either daily or weekly.
- Trial name
- NCT04551573
- Testing
- Rifapentine daily, Rifapentine weekly
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Yale University
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, 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
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Pulmonary Tuberculosis
Evaluation of PTB Screening in ANC in Lusaka, Zambia
This is a pilot pulmonary TB screening program done in three antenatal care clinics in Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and to determine the sensitivity and specificity of…
- Trial name
- NCT02053129
- Testing
- TB screening Questionnaire, Sputum smear and culture (only in HIV negative women who are symptomatic)
- Where
- Zambia
- Volunteers
- 5,033 people
- Sponsor
- University of North Carolina, Chapel Hill
Tuberculosis, Hiv
A One-stop Shop for the Same Day Diagnosis and Management of TB and HIV
TB is a major public health problem and the second most common cause of adult death due to infection in many low-income countries.
- Trial name
- NCT04043390
- Testing
- CRP and Molbio Truenat MTB, CRP and Xpert ULTRA MTB/RIF, standard test Xpert
- Where
- Nigeria
- Volunteers
- 1,100 people
- Sponsor
- Liverpool School of Tropical Medicine
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
Tuberculosis
A Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QFT (+) and (-) Adults Without Evidence of TB
The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete protection against pulmonary tuberculosis.
- Trial name
- C-012-402 (NCT02430506)
- Testing
- AERAS-402
- Where
- Kenya
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infections, Tuberculosis
TB-LAM in the Diagnosis of TB
Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients.
- Conditions
- HIV Infections, Tuberculosis, Non-Tuberculous Mycobacterial Pneumonia
- Trial name
- NCT04600232
- Testing
- Alere TB-LAM
- Volunteers
- 400 people
- Sponsor
- Shanghai Public Health Clinical Center
Chronic Kidney Diseases, Diabetes Mellitus
Prevalence of Chronic Kidney Disease (CKD) and Risk Factors in Sub-Saharan Africa
Prospective cross-sectional study at the outpatient clinic (OPC) of the Bagamoyo District Hospital (BDH) in Tanzania. Assessment of basic epidemiological data (Point prevalence and risk factors) on CKD with simple clinical…
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Hypertension, Tuberculosis
- Trial name
- RenalOne (NCT03458338)
- Testing
- estimated glomerular filtration rate and albuminuria
- Where
- Switzerland
- Volunteers
- 1,006 people
- Sponsor
- University Hospital, Basel, Switzerland
HIV Infections, Tuberculosis
Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis
The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis (TB).
- Trial name
- NCT00004736
- Testing
- Nelfinavir mesylate, Ethambutol hydrochloride, Isoniazid
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)