SPONSOR

National Institute of Allergy and Infectious Diseases (NIAID)

Total Trials

Recruiting

Phases

Phase 1, Phase 1, Phase 2, Phase 2

Conditions studied: HIV Inflammatory Bowel Disease Ulcerative Colitis Chrohn's Disease Cryptococcal Infection Cryptococcal Pneumonia Pulmonary Cryptococcosis Cryptococcal Meningitis Cryptococcosis Liver Transplant

The National Institute of Allergy and Infectious Diseases (NIAID) is a component of the US National Institutes of Health dedicated to understanding, treating, and preventing infectious, immunologic, and allergic diseases. With an annual budget exceeding $6 billion, NIAID supports the largest network of publicly funded infectious disease clinical trials in the world, spanning HIV, tuberculosis, malaria, emerging viral pathogens, influenza, respiratory viruses, immune-mediated diseases, and now long COVID.

NIAID's clinical trial infrastructure includes the HIV/AIDS Clinical Trials Networks (ACTG, HVTN, IMPAACT, MTN), the Collaborative Antiviral Study Group (CASG), the Asthma and Allergic Diseases Cooperative Research Centers, the Precision Vaccines Program, and the COVID-19 Prevention Network (CoVPN). During the COVID-19 pandemic, NIAID-managed the ACTIV consortium — Accelerating COVID-19 Therapeutic Interventions and Vaccines — that rapidly initiated and coordinated master protocols across dozens of candidate therapeutics and vaccines including remdesivir, baricitinib, and molnupiravir.

Beyond infectious disease, NIAID funds trials in primary immune deficiency disorders, autoimmune conditions including type 1 diabetes, lupus, and IBD, and severe allergic conditions including food allergy (including landmark peanut allergy desensitization trials), eosinophilic esophagitis, and mastocytosis. NIAID-sponsored trials often incorporate biospecimen banking and deep immune phenotyping to advance mechanistic understanding alongside clinical endpoints.

Frequently Asked Questions — National Institute of Allergy and Infectious Diseases (NIAID)

What HIV clinical trials does NIAID sponsor?

NIAID is the world's largest public funder of HIV clinical research. Through the AIDS Clinical Trials Group (ACTG), NIAID supports trials on HIV treatment optimization (simplification regimens, long-acting injectables including cabotegravir and rilpivirine), HIV cure strategies (broadly neutralizing antibodies, latency reversal agents, gene editing approaches), and HIV-associated comorbidities (cardiovascular disease, neurocognitive impairment, kidney disease). The HIV Vaccine Trials Network (HVTN) runs preventive vaccine trials globally. IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials Network) focuses on pregnant women and children with or at risk of HIV. Enrollment sites span the US, sub-Saharan Africa, Latin America, and Asia.

Does NIAID fund trials on allergic diseases and immune conditions?

Yes. NIAID's allergy and immunology program is substantial. The Consortium for Food Allergy Research (CoFAR) has conducted foundational trials on peanut, egg, and milk oral immunotherapy and helped establish the evidence base for FDA-approved peanut allergy treatment (AR101/Palforzia). NIAID also funds trials on atopic dermatitis, eosinophilic gastrointestinal disorders, asthma phenotyping, and primary immune deficiency disorders. The Immune Tolerance Network (ITN) focuses on therapeutic tolerance induction in transplantation, autoimmunity, and allergy — with active trials in type 1 diabetes, lupus nephritis, and multiple sclerosis.

Is NIAID involved in COVID-19 and long COVID research?

NIAID played a central role in COVID-19 clinical trial coordination through the ACTIV consortium, which operated master protocols testing antivirals, immunomodulators, and convalescent plasma across hundreds of sites simultaneously. NIAID funded the ACTT (Adaptive COVID-19 Treatment Trial) series — ACTT-1 through ACTT-4 — which generated pivotal data on remdesivir, baricitinib, and abatacept. For long COVID (post-acute sequelae of SARS-CoV-2, PASC), NIAID manages the RECOVER Initiative with $1.15 billion in funding, supporting a national cohort study and multiple Phase 2 platform trials testing antivirals, anti-inflammatory agents, and pacing protocols for fatigue and cognitive symptoms.

National Institute of Allergy and Infectious Diseases (NIAID)

Frequently Asked Questions — National Institute of Allergy and Infectious Diseases (NIAID)

Clinical Trials by National Institute of Allergy and Infectious Diseases (NIAID)

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

Immune Regulation in Ulcerative Colitis or Crohn s Disease

Fungal Infection Susceptibility

Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection

EVR and EPO for Liver Transplant Tolerance

Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease

Advancing Transplantation Outcomes in Children

Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays

Evaluation, Treatment, and Follow-up of Patients With Lyme Disease

Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)

The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise

Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Tocilizumab in Lung Transplantation

Viral Load in Blood and Lymph Tissues in People Living With HIV

Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies

Evaluation of Patients With Immune Function Abnormalities

Immune Regulation in Patients With Common Variable Immunodeficiency and Related Inborn Errors of Immunity (IEI)

Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients

Screening Volunteers for Clinical Trials

Natural History and Genetics of Food Allergy and Related Conditions

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins

Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection