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National Institute of Allergy and Infectious Diseases (NIAID)

Total Trials
19
Recruiting
19
Phases
Phase 3, Phase 1, Phase 2, Phase 1, Phase 2

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.

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

NCT04047628 Phase 3
Recruiting

Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)

Relapsing Multiple Sclerosis
NCT00001205
Recruiting

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Cysticercosis
NCT04052022
Recruiting

Paradoxical Tuberculosis Reactions in Patients Without HIV Infection

Tuberculosis
NCT02257892
Recruiting

Novel Genetic Disorders of the Immune System

PI3KCD
NCT06832189 Phase 1
Recruiting

EVR and EPO for Liver Transplant Tolerance

Liver Transplant
NCT00001355
Recruiting

Detection and Characterization of Host Defense Defects

Immune Defects
NCT07108387 Phase 2
Recruiting

Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis

Giant Cell Arteritis (GCA)
NCT00028080
Recruiting

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

Lyme Disease
NCT05189925 Phase 1
Recruiting

NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)

Chronic Granulomatous Disease
NCT00039689
Recruiting

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants

HIV
NCT03206099
Recruiting

NIAID Centralized Sequencing Protocol

Atopy
NCT01222741
Recruiting

Studies of Disorders With Increased Susceptibility to Fungal Infections

Fungal Infections
NCT00090662
Recruiting

Collection of Data and Samples From Healthy Donors for Use in Translational Research

Healthy Volunteer
NCT06280950 Phase 2
Recruiting

Expanding Liver Transplant Immunosuppression Minimization Via Everolimus

Liver Transplant
NCT07549503 Phase 2
Recruiting

Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation

Liver Transplant
NCT06919003 Phase 2
Recruiting

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

Kidney Transplant
NCT06974877 Phase 1
Recruiting

Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure Changes in Organ-Specific Amyloid Load

Cryopyrin-Associated Periodic Syndromes
NCT05272241
Recruiting

Registry of Asthma Characterization and Recruitment 3 (RACR3)

Asthma
NCT03167437 Phase 1, Phase 2
Recruiting

An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab

Crohn's Disease
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