Clinical trials: sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Dengue
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a…
- Trial name
- NCT05048875
- Testing
- Cohort 1 - Group 1 JNJ High Dose, Cohort 1 - Group 2 JNJ Medium Dose, Cohort 1 - Group 2 JNJ Low Dose
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplantation, Renal Transplantation
Tolerance by Engaging Antigen During Cellular Homeostasis
Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ.
- Conditions
- Kidney Transplantation, Renal Transplantation, Renal Transplant Recipient
- Trial name
- TEACH (NCT03504241)
- Testing
- Donor-derived Mesenchymal Stromal Cells, alemtuzumab, belatacept
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infected Adults With Controlled Viremia
Safety and Tolerability of AAV8 Delivery of a Broadly Neutralizing Antibody in Adults Living With HIV: a Phase 1, Dose-escalation Trial
Background: The Human Immunodeficiency Virus (HIV) attacks the immune system. Scientists have created a gene that could be transferred to the cells of people with HIV.
- Trial name
- VRC 603 (NCT03374202)
- Testing
- VRC-HIVAAV070-00-GT (AAV8-VRC07)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Heart Transplant
Tocilizumab in Cardiac Transplantation
The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant.
- Trial name
- NCT03644667
- Testing
- tocilizumab, Standard of Care Triple IS
- Where
- 20 sites in United States
- Volunteers
- 385 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gonorrhoea
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae…
- Trial name
- NCT04722003
- Testing
- Meningococcal Group B Vaccine
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS, Tuberculosis
Prevent TB: Choice Architecture for TPT Delivery
Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what the investigators know works and what is actually delivered at the clinic-level…
- Trial name
- NCT04466488
- Testing
- Choice Architecture
- Where
- South Africa
- Volunteers
- 50,798 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Infections
Testing a Barbershop-based HIV Prevention Initiative Among Men
To test community-based approaches to engage heterosexual men at risk for HIV and specifically to assess the feasibility and acceptability of a barbershop based HIV prevention program.
- Trial name
- TRIM (NCT06148584)
- Testing
- General, status-neutral HIV education, HIV self-test kits, Information about where to receive HIV prevention services
- Where
- Uganda
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Primary Heart Transplant, Heart Transplantation
Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation
The primary objective is to evaluate the efficacy of desensitization therapy, which includes VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart transplantation.
- Conditions
- Primary Heart Transplant, Heart Transplantation, Heart Transplant
- Trial name
- NCT01769443
- Testing
- bortezomib, plasmapheresis
- Where
- 14 sites in United States
- Volunteers
- 2 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Tuberculosis Treatment Shortening Trial
Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more…
- Trial name
- NCT00130247
- Testing
- Ethambutol, Isoniazid, Pyrazinamide
- Where
- 3 sites in Brazil, Philippines and 1 more
- Volunteers
- 394 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3)…
- Trial name
- M&M (NCT03844386)
- Testing
- MVA.tHIVconsv3, MVA.tHIVconsv4
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of North Carolina, Chapel Hill
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, Multidrug-Resistant, Tuberculosis
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus Infections, HIV Infections
Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)
A5355 was a randomized, placebo-controlled study conducted at US sites to evaluate the safety and immunogenicity of two injections of the study drug Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine…
- Conditions
- Cytomegalovirus Infections, HIV Infections, Vaccine
- Trial name
- NCT05099965
- Testing
- CMV-MVA Triplex
- Where
- 12 sites in United States
- Volunteers
- 94 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
- Trial name
- SIGA-246-002 (NCT00431951)
- Testing
- ST-246
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Cardiac Allograft Vasculopathy, Heart Transplant Recipients
Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation
All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function.
- Trial name
- NCT01278745
- Testing
- Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
- Where
- 24 sites in United States
- Volunteers
- 362 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Living-Donor Kidney Transplant, Kidney Transplant Recipients
Treg Modulation With CD28 and IL-6 Receptor Antagonists
The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.
- Trial name
- NCT04066114
- Testing
- lulizumab pegol, antithymocyte globulin (rabbit), methylprednisolone
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant, Adult Living Donor Kidney Transplant Recipients
Treg Therapy in Subclinical Inflammation in Kidney Transplantation
The purpose of this study is: To see if polyTregs can reduce inflammation in a transplanted kidney. To find out what effects, good or bad, polyTregs will have in the kidney recipient.
- Conditions
- Kidney Transplant, Adult Living Donor Kidney Transplant Recipients, Renal Transplant, Living Kidney Donor
- Trial name
- TASK (NCT02711826)
- Testing
- Polyclonal Regulatory T Cells, Everolimus, Tacrolimus
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication.
- Trial name
- NCT05605093
- Testing
- Shionogi Protease Inhibitor (S-217622)
- Where
- 187 sites in United States, Argentina and 22 more
- Volunteers
- 602 people
- Sponsor
- University of Minnesota
Kidney Transplantation, Renal Transplantation
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage.
- Trial name
- NCT01436305
- Testing
- Alemtuzumab, MMF, Basiliximab
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)