PEPFAR is the U.S. government initiative to help save the lives of those living with and affected by HIV/AIDS around the world. This historic commitment is the largest by any nation to combat a single disease internationally, and PEPFAR investments also help alleviate suffering from other diseases across the global health spectrum. PEPFAR is driven by a shared responsibility among donors, host countries, and other partners to make smart investments to save lives and, ultimately, end the AIDS epidemic by 2030.
Read more about this network: U.S. President's Emergency Plan for AIDS Relief
Main Areas of Focus
- To identify the most successful and cost-effective strategies for reaching at-risk populations for HIV prevention and treatment interventions
- To control and ultimately end the HIV/AIDS epidemic
Oversight
PEPFAR is led and managed by the U.S. Department of State's Office of the U.S. Global AIDS Coordinator and Health Diplomacy and implemented by seven U.S. government departments and agencies, leveraging the power of a whole-of-government approach to controlling the HIV/AIDS epidemic.
PEPFAR has funded Implementation Science grants through a series of individual NOFOs, released by NIH, CDC, and/or USAID.
Multicenter AIDS Cohort Study (MACS)
The Multicenter AIDS Cohort Study (MACS) was a prospective study originally focused on the natural and treated histories of HIV-1 infection in men who identified as homosexual or bisexual. The study was originally funded in 1984 and by study end in 2019 had been conducted at clinical research sites located in Baltimore, MD/Washington, DC; Chicago, IL; Los Angeles, CA; Pittsburgh, PA/Columbus, OH. Participants were representative of the population of men living within these geographical regions and either living with HIV or behaviorally vulnerable to HIV at the time of enrollment. Biological and behavioral data were collected every six months; limited autopsy samples may be available also. The study was merged with the Women’s Interagency HIV Study (WIHS) under a unified study comprising a cohort of men and women, later known as the MACS-WIHS Combined Cohort Study (MACS-WIHS CCS).
Read more about this network: Multicenter AIDS Cohort Study (MACS)
Main Areas of Focus
- To address the key questions facing HIV research today, including the effects of HIV, cART, and age on HIV-induced inflammation and immune dysfunction and on non-AIDS-defining outcomes including cancer, cardiovascular, liver, metabolic, neurologic, psychologic, and renal disease
- To collect specimens for helping to understand the pathogenesis of HIV-1 infection and the development of disease in HIV-infected people
Contact Information
HIV Vaccine Trials Network (HVTN)
The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV globally. Funding is provided by public and private sources. The National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health, is the primary funder and sponsor of the majority of trials conducted by the HVTN. The Network’s clinical research sites are located at leading research institutions in over in 16 countries on four continents. Internationally renowned researchers in HIV vaccines and prevention lead these units and contribute to the Network’s scientific agenda. The Network’s headquarters are at the Fred Hutchinson Cancer Center in Seattle, Washington.
To date, the Network has conducted the majority of the published, presented, or ongoing clinical trials of preventive HIV vaccines worldwide. In the process, we have gained tremendous experience in implementing an innovative global scientific organization, which combines the intellectual robustness and creativity of academia with the focus and infrastructure of industry.
The HVTN is comprised of the Leadership and Operations Center (LOC), Laboratory Center (LC), Statistical and Data Management Center (SDMC), study clinics , and participants and communities. Each of these components is necessary to conduct our clinical trials.
Read more about this network: HIV Vaccine Trials Network (HVTN)
Main Areas of Focus
- HIV Vaccines - The HVTN vaccine pipeline is currently focused on vaccine regimens that elicit broadly neutralizing antibody (bnAb) responses. An antibody that neutralizes HIV binds to proteins on the surface of the virus and blocks HIV’s ability to bind and infect CD4+ T cells. Neutralizing antibodies are considered ‘broad’ by their ability to neutralize multiple strains of HIV. Recent technological advances have accelerated progress in the isolation and characterization of several different classes of HIV-specific bnAbs. With that information in hand, we can design vaccines that specifically stimulate the production of those bnAbs.
- Broadly Neutralizing Antibody (bnAb) Research - In recent years, the HVTN has paved the way in studying a technique called passive antibody transfer, which involves giving antibodies directly to an HIV-negative person by injections or infusions. Through the AMP Studies, the HVTN determined a broadly neutralizing antibody called VRC01 was effective at preventing the acquisition of HIV to 75 percent of HIV strains that were sensitive to the bnAb. This work has led to further study of combinations of bnAbs that may be more potent or have greater breadth of neutralization.
- Tuberculosis (TB) Research - In partnership with the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), the HVTN is conducting an integrated clinical trials program including immunological, microbiological, and diagnostic technologies to enhance the TB vaccine field globally by evaluating the safety and immunogenicity of TB vaccines.
- COVID-19 Research - As the SARS-CoV-2/COVID-19 pandemic began, the HVTN was asked to apply its community engagement, clinical, statistical, and operational infrastructure to rapidly implement and analyze the U.S. government-supported Phase 3 clinical trials of COVID-19 vaccines. The COVID-19 Prevention Network (CoVPN), funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was formed in spring 2020 to create a coordinated, efficient and scientifically rigorous approach to conduct COVID-19 vaccine efficacy trials and help end the pandemic.
Oversight
- HVTN Executive Management Team
- HVTN Science Governance Committee
- DAIDS Vaccine Research Program and Vaccine Clinical Research Branch
The HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded international collaboration facilitating the evaluation of vaccines to prevent HIV/AIDS. The HVTN helps advance the fields of vaccinology, social and behavioral sciences, statistics, and immunology, as well as tuberculosis and COVID-19 vaccines.
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HIV Prevention Trials Network (HPTN)
The HIV Prevention Trials Network develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV.
Read more about this network: HIV Prevention Trials Network (HPTN)
Main Areas of Focus
- To discover and develop new and innovative research strategies to reduce the acquisition and transmission of HIV
Oversight
The Executive Committee is made up of: Principal Investigators (PIs), International Lead Investigator, Past PI and Co-PI, SDMC PI & LC PI, LOC Director, Community Representative, two NIH Representatives, and two Site Representatives.
HPTN has 51 clinical research sites in 13 countries around the world.
HPTN holds an annual meeting as well as regular regional meetings.
Community Partners (CP)
Community Partners (CP) works to promote effective representation of the many US-based and international communities in which the NIH-funded HIV Clinical Trials Networks conduct research. CP consists of community members from each of the Networks’ Global Community Advisory Boards, community liaison staff, members from the Tuberculosis Trials Consortium Community Research Advisors Group (TBTC CRAG), and the Division of AIDS.
Read more about this network: Community Partners (CP)
Main Areas of Focus
- To facilitate community engagement and involvement within each of the NIH-funded HIV/AIDS clinical trials networks
- To coordinate community input and resources across the clinical trials networks
- To develop training materials and identify resources to support the global and local Community Advisory Boards
- To increase the representation and participation of community members from regions in which the NIH-funded HIV/AIDS clinical trials networks is conducting research
- To identify and address challenges to participation in clinical trials
Network Oversight
The Community Partners Executive Committee (CP Exec. Committee) makes decisions on behalf of Community Partners and its general membership in accordance with CP Organizational Guidelines.
Contact Information
Centers for AIDS Research (CFAR)
The Centers for AIDS Research (CFAR) program at the National Institutes of Health provides administrative and shared research support to synergistically enhance and coordinate high quality AIDS research projects. CFARs accomplish this through core facilities that provide expertise, resources, and services not otherwise readily obtained through more traditional funding mechanisms.
The Ending the HIV Epidemic in the U.S. (EHE) initiative was launched in 2019 by the U.S. Department of Health and Human Services (HHS) with the goal to end the HIV epidemic in the U.S. within 10 years. To achieve this goal and address the ongoing public health crisis of HIV, EHE will leverage the powerful data and tools now available to reduce new HIV infections in the United States by 75 percent in five years and by 90 percent by 2030. The Centers for AIDS Research, along with the National Institute of Mental Health's AIDS Research Centers, have played a key role in informing HHS partners in this initiative on best practices based on state-of-the-art biomedical research findings, and by collecting and disseminating data on the effectiveness of approaches used in this initiative.
Between 2019-2023, NIH announced supplemental awards to the CFARs and ARCs to support research to enhance the implementation science knowledge base needed for EHE. These projects required partnerships between academic researchers and community partners to determine how best to get effective prevention and treatment tools to the people who need it. Additionally, the NIH is supporting a coordinating and data management center, the Implementation Science Coordination Initiative (ISCI), and multiple implementation research consultative hubs across the U.S. to develop generalizable knowledge from local knowledge by encouraging the use of shared implementation frameworks and harmonized measures, synthesizing data across projects, and encouraging cross-project collaboration. New EHE funding in 2024 and beyond will support larger independent research projects, including investigator-initiated projects outside of the CFARs and ARCs. However, the partnerships and knowledge base built by these institutes will continue to play a large role in the EHE initiative.
Main Areas of Focus
- To support multidisciplinary research aimed at reducing the burden of HIV both in the United States and around the globe
- Read more about CFAR’s mission
Oversight
The CFAR Program is administratively managed by the CFAR team within the Basic Science Program within the Division of AIDS at NIAID and it is scientifically managed by the NIH CFAR Steering Committee, comprised of representatives from the co-funding institutes and centers as well FIC and the Office of AIDS Research.
Contact Information
- General program information: CFARprogram@mail.nih.gov
- Information about CFAR sites: Contact the site directly
This program was originally begun by the NIAID Division of AIDS in 1988 and is co-funded by eleven NIH Institutes.
There are 19 Centers for AIDS Research (CFARs) located at academic and research institutions throughout the United States.
Limited resources may be available to outside researchers depending upon individual CFAR policies and availability.
One of the missions of the CFAR Program is to foster CFAR–CFAR collaborations. Over the past few years, several inter-CFAR collaborations have been formed by the CFARs.
CFAR holds an annual meeting.
DAIDS Services Program to Accelerate Drug Development
The Division of AIDS (DAIDS) maintains contracts that can potentially provide limited pre-clinical resources and services to investigators who are working on the development of therapeutics targeting HIV and HIV-associated co-infections, including hepatitis B virus (HBV), hepatitis C virus (HCV) and Tuberculosis (TB). The focus of the program is to facilitate the advancement of promising drug candidates from bench to clinic and fill critical program and resources gaps in an investigator’s drug development efforts as they advance their product toward regulatory submissions and clinical trials.
Areas of Focus
- DAIDS is especially interested in the development of next-generation therapies for HIV and HIV-associated co-infections with improved safety and ease of use including sustained release therapeutics, novel HIV targets & inhibitors, and novel immune-based therapies.
- Projects in both the early and late stages of preclinical development are suitable for support under this program.
- Experimental therapeutics may include small organic molecules, polymers, or biologics (e.g., peptides, oligonucleotides, antibodies), as well as cellular and genetic drug products (e.g., CAR-T cells).
Support Services
Available services are offered in the following areas:
A) In Vitro Testing and Screening of HIV Compounds
- High throughput screening of compound libraries in cell-based or biochemical assays
- Testing in human peripheral blood mononuclear cells (PBMCs) and/or continuous cell lines to confirm the activity of anti-HIV therapeutic agents
- Hit-to-Lead progression studies
- HIV drug resistance testing
B) Synthesis of Therapeutic Agents
- Chemical synthesis of small molecule lead compounds for use in additional drug development studies. Requested product must be of known chemical structure and have already been successfully synthesized. Synthesis of new analogs is not supported.
- Investigators provide the synthetic schemes to be followed; NIAID contractors will modify or optimize problematic steps as necessary.
- Complexity and cost will limit potential scale-up efforts, but synthesis of up to 1 kilogram of a simple small molecule often can be accommodated.
- Drug substances can be synthesized under GMP guidelines.
- Investigators must have preliminary data to support the continued development of the product.
C) Evaluations in Small Animal Models for HIV, HBV, HCV and TB
- Pharmacokinetic (PK), safety, and efficacy studies to characterize products, inform dose selection, optimize formulations, and/or obtain other information necessary to advance or support product testing in subsequent large animal or human studies (supported under different mechanisms).
- Assessment of mainly therapeutics, but also vaccines, other prophylactic methods, and diagnostics for use against HIV, HBV, HCV and TB in small animal models.
- When applicable, other activities (e.g., immunology, histopathology, in situ hybridization, whole body and tissue imaging, etc.) may be supported.
D) Formulation Development and Manufacture of Clinical Dosage Forms
- Development of alternative dosage forms (strength, physical form, route of administration) and new formulations to improve drug properties.
- Development and validations of analytical assays.
- Drug product manufacturing and stability studies in compliance with GMP guidelines.
E) Preclinical Pharmacology and Toxicology
- Pharmacokinetic studies in animal species.
- Good Laboratory Practice (GLP) compliant toxicology and safety pharmacology studies.
- In vitro Absorption, Distribution, Metabolism, Elimination, Toxicity (ADMET) studies.
- Development of new toxicology models and test systems, such as 3-dimensional culture, hollow-fiber cell culture, or organ-on-a-chip technology.
Eligibility Requirements
Investigators seeking access to DAIDS resources must be conducting research for treatment of HIV and HIV-associated co-infections (HBV, HCV or TB) and have a defined drug development program. Services requested are expected to be narrowly focused to fill gaps in areas of need. Investigators are not required to have current NIH funding to apply. It is expected that resources other than those supported by DAIDS preclinical services will be sought or in place to complete the drug development program. Requested services may not overlap with efforts already funded through the Department of Health and Human Services.
These DAIDS services are not intended for Investigators seeking to develop untested ideas or ideas based on extrapolation of data obtained with structurally—or functionally—similar products. NIAID supports these latter types of activities via one of its grant mechanisms.
By accepting the data package for review, DAIDS does not guarantee funds will be available for services. The provision of services to an investigator depends on several factors, including technical merit, relative program priority, and available funds.
Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf. These services are provided at no cost to the investigator.
For more information contact DAIDS staff at niaiddaidsdptdc@mail.nih.gov.
DAIDS Preclinical Therapeutic Development Committee (DPTDC)
The DPTDC can be contacted via email at niaiddaidsdptdc@mail.nih.gov.
U.S. Military HIV Research Program (MHRP)
The U.S. Military HIV Research Program (MHRP) was established in 1985 to protect U.S. troops entering endemic HIV areas and is dedicated to HIV vaccine development, prevention, disease surveillance, and HIV care and treatment. NIAID plans and executes HIV/AIDS research projects annually with MHRP through an interagency agreement on HIV vaccine research.
Read more about this network: U.S. Military HIV Research Program (MHRP)
Main Areas of Focus
- To protect the U.S. Military from HIV
- To improve global health by conducting research to develop an HIV vaccine, reduce new infections and find a cure
Oversight
The Walter Reed Army Institute of Research (WRAIR) at the US Military Research and Materiel Command (MRMC) and the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID) have agreed to coordinate their efforts to maximize each agency's resources, fulfill their respective missions, and streamline the operational and scientific aspects of clinical trials. Both agencies stress the importance of robust oversight of the jointly developed Interagency Agreement (IAA) through coordinated planning and systematic review of the Military HIV Research Program’s (MHRP) HIV/AIDS research initiatives. A detailed, multi-year research plan, created following the MRDC guidelines, undergoes annual programmatic and resource evaluations by the Military Infectious Diseases Research Program (MIDRP) to ensure it aligns with the missions of both agencies. Oversight is further strengthened by external peer reviews of project proposals and progress reports, with DAIDS staff assessing scientific merit and relevance to their research priorities. DAIDS and MIDRP jointly manage funding decisions.
Contact Information
MHRP Headquarters
6720A Rockledge Drive Suite 400
Bethesda, MD 20817
There are multiple MHRP locations both domestic and abroad.
Center for HIV/AIDS Vaccine Development (CHAVD)
CHAVD are two consortia established by NIAID to develop and select through iterative design HIV immunogens and regimens that induce broadly neutralizing antibody (bNAb) responses for advancement into clinical testing. The two seven-year awards were made in 2019, one to the Duke Human Vaccine Institute (DHVI) and another to the Scripps Research Institute. These awards represent the third iteration of the Center for HIV/AIDS Vaccine Immunology (CHAVI), which DHVI led from 2005-2012. that initial award was followed by two other seven-year grants (Center for HIV/AIDS Vaccine Immunology & Immunogen Discovery (CHAVI-ID) awarded to DHVI and Scripps Research in 2012.
Main Areas of Focus
- Identifying in humans the specificity and functionality of the antibody and other immune responses at different anatomical locations that can provide protective immunity by vaccination by contributing durable broad-coverage virus-neutralizing responses.
- Studying envelope isolates and exploring immunogens, adjuvants, delivery technologies, and regimens that induce different specificities of broad and durable protective neutralizing antibody responses.
- Performing proof-of-concept active and passive protection studies in nonhuman primates or other relevant animal models.
- Designing and performing GMP manufacturing process development and manufacturing candidate immunogen constructs for iterative phase I clinical studies.