NIH Begins Clinical Trial of Hydroxychloroquine and Azithromycin to Treat COVID-19

A NIAID-sponsored clinical trial has begun to evaluate whether the malaria drug hydroxychloroquine can prevent hospitalization and death from COVID-19.

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CHEETAH Center for the Structural Biology of HIV Infection, Restriction and Viral Dynamics

CRNA—Center for Structural Biology of HIV RNA

Centers for HIV Structural Biology

The Centers for HIV Structural Biology, established in 2007 by the National Institute of General Medical Sciences (NIGMS), integrate a variety of techniques from structural biology, biochemistry and cell biology to capture in unprecedented detail the three-dimensional structures of HIV proteins and nucleic acids and their interactions with cellular components. This information will help elucidate how the different components interact and reveal new approaches for disrupting those interactions, potentially leading to new targets for HIV therapies and preventive vaccines.

The Center awards were transferred from NIGMS to NIAID in 2019 as a part of the consolidation of AIDS basic research projects in the NIAID Division of AIDS. The program was continued in 2022 with the funding of six new Centers. The Centers include research across the HIV life cycle, aiming, for example, to elucidate the mechanism the HIV envelope protein uses to enter a target cell, the interactions of virus structures with host proteins that either facilitate or antagonize infection, and the way that the HIV RNA genome folds into complex assemblies with other viral components before being packaged into newly formed virions. 

Main Areas of Focus

  • Structural Biology of HIV, molecular complexes, and HIV / host cell complexes including proteins, nucleic acids and pharmacologic inhibitors.
  • Identification of new host cell factors involved in HIV replication and restriction
  • Identification of new targets for anti-HIV drug development and vaccine design

Contact Information

David McDonald, PhD, Basic Sciences Program, Division of AIDS, NIAID

Locations
Funding

RFA-AI-21-030: Centers for HIV Structural Biology (U54)
RFA-AI-22-050: Molecular Dynamics of HIV (R01 Clinical Trial Not Allowed)
NIAID Funding News: Molecular Dynamics of HIV Funding Opportunity 

Events

2025 HIV Structural Biology Virtual Meeting
Monday, June 23 - Tuesday, June 24, 2025
Open to U54 Structure Center Members
Pre-registration required

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Immune Mechanisms of Protection Against Mycobacterium tuberculosis Centers (IMPAc-TB)

The Immune Mechanisms of Protection Against Mycobacterium tuberculosis Centers (IMPAc-TB) program is an initiative established by NIAID in 2019 to elucidate the immune responses needed to protect against infection with Mycobacterium tuberculosis (Mtb). The program will lead to a  better understanding of tuberculosis (TB) immunology, which is critical to guide the design and development of new and improved TB vaccines, and it aligns with the goals of the NIAID Strategic Plan for Tuberculosis Research.

Main Areas of Focus

The IMPAc-TB program aims to develop a comprehensive understanding of the immune responses required to prevent initial infection with Mtb, establishment of latent infection, and transition to active TB disease. To accomplish these objectives, multidisciplinary research teams will conduct immunological analyses of tissue-specific and systemic responses in small animals, non-human primates (NHPs), and humans to identify the key immune responses needed for protection against Mtb; identify immunologic targets that can be used to improve TB vaccine strategies; determine the impact of human immunodeficiency virus (HIV)/simian immunodeficiency virus (SIV) and nontuberculous mycobacteria (NTM) infections on relevant immune responses to Mtb infection or TB vaccines; and identify how bacterial immune evasion mechanisms subvert immune responses to Mtb.

Locations

Harvard T.H. Chan School of Public Health, Boston

Principal investigators: Sarah Fortune, M.D. (Harvard); Henry Boom, M.D. (Case Western Reserve University, Cleveland); JoAnne Flynn, Ph.D. (University of Pittsburgh)           

Center objective: The goal of this Center is to identify factors that protect people from Mtb infection and to translate these findings into improved vaccine strategies. A multidisciplinary research team will assess samples from NHPs and human cohorts, in whom infection is suppressed, to learn how their immune responses protect them from Mtb infection.  Investigators will use computational modeling to predict the likely causes of suppressed infections, which will be tested in cellular and small animal models. Studies will evaluate the effect of intravenous (IV) bacille Calmette-Guerin (BCG) vaccination in rhesus macaques in response to Mtb challenge and the immune mechanisms responsible for controlling natural mycobacterial infection in cynomolgus macaques. Studies also will examine the effect of SIV infection on IV BCG vaccination using computational modeling and a systems biology approach. In collaboration with the Imperial College of London, the research team will compare the immune correlates of protection observed in the NHP studies with human responses. Human studies conducted by the Center also will also focus on exposed individuals that resist infection or that develop a transient infection response.

Seattle Children's Hospital

Principal investigator: Rhea Coler, Ph.D. 

Center objective: This Center will identify the complex immune responses required to prevent Mtb infection or active TB disease by comparing and examining protective immune responses induced by natural mycobacterial infection or vaccines. The research team will evaluate recombinant protein vaccines combined with adjuvants to identify and validate common protective correlates of immunity in well-established animal models for TB and human challenge clinical studies where participants are deliberately exposed to BCG under carefully controlled conditions. The investigational vaccines to be evaluated are ID93 and M72 formulated with GLA-SE and other adjuvants developed by IDRI and contractors supported by NIAID’s Division of Allergy, Immunology, and Transplantation (DAIT). The studies also will address how immunity from previous BCG vaccination and natural nontuberculous mycobacteria  (NTM) infection affects the investigational vaccines’ effectiveness and ability to generate an immune response across species. The studies will provide crucial insights into the development of candidate vaccines that generate robust levels of durable, protective immunity against TB.

Seattle Children’s Hospital 

Principal investigator: Kevin Urdahl, M.D., Ph.D.

Center objective:  The goal of this Center is to inform the design of an effective TB vaccine by identifying the immune responses capable of controlling and potentially eradicating Mtb. The research team will identify and examine protective pathways in natural and vaccine-induced immunity by analyzing tissue-specific and systemic immunity in mice, NHPs, and humans. Investigators will examine immune correlates at three stages: the pre-infection immune stage; the early events after pulmonary infection; and the formation of granulomas (compact, organized structures of immune cells) during chronic infection. These studies will identify the immune responses required to protect the host from initial infection, establish latent infection, and prevent progression to active TB disease.

Contact Information

Dr. Que Dang - Division of AIDS (DAIDS)

Dr. Nancy Vázquez, Division of Allergy, Immunology, and Transplantation (DAIT)

Dr. Katrin Eichelberg, Division of Microbiology and Infectious Diseases (DMID)

Publications

Dang Q et al. Immune mechanisms of protection against Mycobacterium tuberculosis-centers. 2024 Oct 8:15:1429250. doi: 10.3389/fimmu.2024.1429250. eCollection 2024.

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Martin Delaney Collaboratories for HIV Cure Research (MDC)

The Martin Delaney Collaboratories for HIV Cure Research is the flagship NIH program on HIV cure research. The purpose is to foster dynamic, multidisciplinary collaborations between basic, applied, and clinical researchers studying HIV persistence and developing potential curative strategies. This is accomplished by establishing partnerships across academia, industry, government, and community, with a goal of leveraging common resources to accelerate the pace of HIV cure research and engage the next generation of HIV cure researchers.

The program was launched in July 2011 with the funding of three Collaboratories: CARE, DARE, and defeatHIV. In July 2016, the program was expanded to include three additional Collaboratories (BELIEVE, BEAT-HIV, and I4C) for a total of six Collaboratories. In 2021, the program was further expanded to include a total of 10 Collaboratories (CARE, DARE, BEAT-HIV, I4C, REACH, ERASE-HIV, CRISPR for Cure, PAVE, RID-HIV, and HOPE), with one of them (PAVE) focused specifically on HIV cure research in infants and children. The combined program supports a network of approximately 300 Collaboratory members.  

Main Areas of Focus

  • Basic and clinical research to characterize persistent HIV reservoirs and to determine the mechanisms associated with viral latency, post-treatment control, and viral rebound
  • Applied research to develop and test therapeutic strategies for eradicating or controlling residual virus using in vitro, ex vivo, and animal models
  • Designing clinical trial protocols to test safety, tolerability, and initial proof-of-concept of curative therapies
  • Community engagement to advance research literacy, set realistic expectations of success, and address potential concerns regarding acceptability, enrollment, safety, or ethics

Oversight

The Pathogenesis and Basic Research Branch and the Targeted Interventions Branch of the Basic Sciences Program in DAIDS coordinate with the Maternal, Adolescent and Pediatric Research Branch of the Prevention Sciences Program in DAIDS to oversee the MDC program by convening an MDC Program Management Team made up of representatives from other Branches, Programs, and Divisions of NIAID, along with the co-funding Institutes (NICHD, NIDA, NIMH, NIDDK, NHLBI, and NINDS) and the NIH Office of AIDS Research.

Contact Information

Karl Salzwedel – Chief, Pathogenesis and Basic Research Branch, DAIDS

Sandra Bridges – Chief, Targeted Interventions Branch, DAIDS

Patrick Jean-Philippe – Chief, Maternal, Adolescent and Pediatric Research Branch, DAIDS
 

Past Events

Joint MDC Satellite Meeting, December 13, 2022, held in conjunction with the 2022 HIV Persistence During Therapy International Workshop

Locations

Grantee Institutions

  • Beth Israel Deaconess Medical Center
  • Emory University, Gladstone Institutes
  • Johns Hopkins University
  • Scripps Research
  • Temple University
  • University of California San Francisco
  • The University of North Carolina at Chapel Hill
  • Weill Cornell Medicine
  • The Wistar Institute
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Networks & Programs

Genetic Delivery of HIV mAb Workshop

Division of AIDS Clinical Quality Management Plan (CQMP) Frequently Asked Questions

Process Development and Analytical Support Contract (PAS)

The Process Development and Analytical Support Contract (PAS) supports two key critical components: process development and analytical characterization activities. 

This contract is with the International AIDS Vaccine Initiative (IAVI).

Preclinical Development Support Master Contract (PDSMC)

The Preclinical Development Support Master Contract (PDSMC) supports all phases of preclinical development, including process and product development, GMP manufacturing and clinical lot production, analytical and formulation, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications.

This contract is with Advanced Bioscience Laboratories (ABL).