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R&D across health areas | HIV/AIDS

R&D for HIV/AIDS

How new tools can transform the fight

Since emerging in the 1980s, the global HIV pandemic has claimed the lives of more than 44 million people around the world—reversing gains in life expectancy, health outcomes, and economic development in the world’s most under-resourced places. The development of antiretroviral drugs (ARVs) turned the trajectory of the HIV pandemic, extending the life expectancy and overall well-being of people living with HIV and preventing transmission between mothers and children, as well as people of different HIV statuses.

Yet, progress toward ending HIV as a public health threat has slowed in recent years, and major gaps remain in our arsenal of treatment and prevention tools. We will not bring about an end to the HIV pandemic without new and improved technologies.

  • 40.8 million
    people living with HIV/AIDS
  • 1.3 million
    people became newly infected with HIV in 2023
  • 250 children
    die every day from AIDS-related causes

Research successes

Technologies have transformed the fight against HIV/AIDS:

  • ARVs—developed with NIH support—are today used to treat 31.6. million people globally and have averted 16.5 million AIDS-related deaths since 2001.
  • Pre-exposure prophylaxis (PrEP)—the use of ARVs to prevent HIV infection—was shown to be effective through NIH, CDC, and USAID research and is now being scaled up globally.
  • Approaches to prevent mother-to-child HIV transmission—developed with NIH support—have contributed to a 62% decline in new infections in children since 2010.
  • New long-acting PrEP options, including a monthly vaginal ring, developed with NIH and USAID support, and bi-monthly and twice-yearly injectables, developed with NIH support, now offer alternatives to taking daily pills.
  • Child-friendly therapies—including a quick-acting, dissolvable formulation supported by NIH—are improving care for children living with HIV.
  • Diagnostic innovations, including oral fluid, blood-based, and urine-based self-tests are increasing testing options and expanding access. Dual and multiplex tests that simultaneously detect HIV and other infections such as syphilis and hepatitis B are supporting integrated care and reducing the costs and complexity of health care services.
  • Recency tests, which indicate whether an HIV infection likely occurred within the past year, are used in surveillance to estimate HIV incidence and track epidemic trends, helping target resources and services to areas of active or emerging transmission.

Continued progress is possible, not inevitable Continued progress is possible, not inevitable

Continued progress is possible, not inevitable

Key missing tools Key missing tools

To end HIV, we need new prevention, diagnostic, and treatment tools, including:

  • Expanded HIV treatment and PrEP options to meet diverse needs, improve adherence, and safeguard long-term effectiveness, including:
    • Additional long-acting options, fixed-dose combinations, and/or simplified regimens with fewer side effects to improve adherence.
    • Additional microbicide options to prevent infections among women and gay men and other men who have sex with men, populations disproportionately impacted by the pandemic.
    • On-demand PreP solutions that can be initiated at the time of sex.
    • Expanded, child-appropriate therapies that are safe, palatable, and easy to administer for infants and young children.
    • Novel treatment options to address drug resistance to existing regimens.
    • Additional multipurpose prevention technologies that simultaneously prevent HIV, other sexually transmitted infections, and unintended pregnancy.
  • Vaccines to prevent and reduce new infections.
  • Enhanced point-of-care tools to rapidly diagnose HIV in newborns to enable earlier treatment initiation and reduce infant mortality, as well as point-of-care viral load testing solutions that can enable earlier and decentralized treatment monitoring.
  • A cure to control infection or eliminate it from the body.

Breakthroughs on the brink Breakthroughs on the brink

  • Long-acting biomedical products that could revolutionize both HIV treatment and prevention in hard-to-reach populations by reducing frequency of use and providing a more discreet, convenient alternative to daily pills. Products now in development include a once-weekly ARV pill for treatment, a monthly oral PrEP pill, a three-month vaginal ring for prevention, a once-yearly injectable preventative drug, and implants that slowly release anti-HIV drugs over time for continuous protection.
  • Multipurpose prevention products—including pills, injections, films, and vaginal rings that combine HIV protection with contraception—could provide more convenient options, particularly for women. The two products furthest in development are a dual prevention pill and a multipurpose vaginal ring, both of which were advanced with USAID and NIH support.
  • On-demand prevention options that can be initiated at the time of sex, including a fast-dissolving vaginal insert, advanced with USAID support, that releases ARVs at the site of exposure, which could provide women with a discreet, easy-to-use prevention solution that requires no long-term commitment.
  • Many clinical trials are underway to test broadly neutralizing antibodies (bNAbs)—proteins shown to neutralize many different genetic variants of HIV—as treatment and prevention products delivered via infusion or injection. These include trials of several bNAbs developed or isolated at NIH labs, as well as a combination treatment expected to enter Phase 3 trials soon, the most advanced bNAbs-based treatment to date.
  • Several mRNA-based HIV vaccine candidates have advanced into first-in-human trials, including candidates supported by NIH, USAID, and DoW, bringing new hope to the quest for an HIV vaccine. Additionally, new vaccine research strategies are reinvigorating the field, including approaches to induce bNAbs such as germline targeting, which uses a series of stepwise shots to coax the immune system to create bNAbs, and T-cell approaches, which induce T cells that act as either killer cells to directly attack the virus or helper cells that support other B cells to generate antibodies against HIV.
  • Several child-focused HIV technologies in development aim to close gaps in prevention and treatment early in life, including an NIH‑supported trial of an experimental HIV vaccine for infants, as well as a trial to establish dosing recommendations for a child‑friendly formulation of the drug dolutegravir for infants under one month old, a group for which no approved or guideline-recommended formulations exist.
  • Point‑of‑care HIV viral load testing technologies now in development could shift treatment monitoring out of centralized laboratories and into clinics and communities, enabling same-visit results and improving care retention. Several promising platforms are being advanced with NIH support, including through its RADx program.
  • Ten patients appear to have been effectively cured of HIV or are in long-term remission, demonstrating that a cure for HIV infection, while difficult, is scientifically possible. Several cure strategies are also advancing in the research pipeline, including a “kick and kill” approach to prompt latent HIV to reactivate so it can be targeted and neutralized and gene modification approaches to change human DNA in immune cells to produce cells that are resistant to HIV.

US government investment in HIV/AIDS R&D for low-resource settings (in 2022) US$ millions

Breakthroughs on the brink
US Government R&D efforts US Government R&D efforts

The US government is leading efforts to advance research and development (R&D) to end HIV as a public health threat through a whole-of-government approach:

  • National Institutes of Health (NIH) conducts basic and clinical research to advance products to prevent, diagnose, and treat HIV, as well as social behavioral research to improve the uptake and continued use of existing interventions.
  • Department of State supports the introduction, delivery, and scale-up of HIV products and services globally through the President’s Emergency Plan for AIDS Relief (PEPFAR) and other programming. With the integration of the US Agency for International Development (USAID), the State Department has the opportunity to support R&D efforts for HIV prevention products and multipurpose tools designed for low-resource settings, efforts previously led by USAID.
  • Department of War (DoW) undertakes research to protect US service members, including vaccine research.
  • Centers for Disease Control and Prevention (CDC) supports countries to strengthen surveillance, laboratory, and digital health information systems capacity, as well as generates research and evidence to scale up effective use of HIV products and services worldwide.
  • Food and Drug Administration, alongside approving products for use in the United States, operates a tentative regulatory approval program to allow PEPFAR to distribute generic ARVs for use outside the United States.

Introduction

40.8 million living, 1.3 million newly infected, 44 million deaths: UNAIDS. Global HIV & AIDS statistics — Fact sheet.Accessed February 9, 2026https://www.unaids.org/en/resources/fact-sheet

250 children: UNICEF. Global and regional trends. July 2025. Accessed February 9, 2026.https://data.unicef.org/topic/hivaids/global-regional-trends/

Research successes

ARVs, developed with NIH support: National Institute of Allergy and Infectious Diseases. Antiretroviral drug discovery and development. Accessed August 8, 2024. https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drug-development

ARVs, used to treat 36.1 million people: UNAIDS. Global HIV & AIDS statistics — fact sheet. Accessed February 9, 2026. https://www.unaids.org/en/resources/fact-sheet

ARVs, averted 16.5 million AIDS-related deaths: UNAIDS. Global roll-out of HIV treatment has saved millions of lives. September 6, 2021. Accessed February 9, 2026. https://www.unaids.org/en/resources/presscentre/featurestories/2021/september/20210906_global-roll-out-hiv-treatment

Pre-exposure prophylaxis: The Global PrEP Tracker. AVAC; 2026. Accessed February 9, 2026. https://data.prepwatch.org/

Pre-exposure prophylaxis, shown to be effective through NIH research: US National Institutes of Health National Institute of Allergy and Infectious Diseases. Pre-exposure prophylaxis (PrEP) to prevent HIV. Accessed February 9, 2026. https://www.niaid.nih.gov/diseases-conditions/pre-exposure-prophylaxis-prep

Pre-exposure prophylaxis, shown to be effective through CDC research:

Nicol MR, Adams JL, Kashuba AD. HIV PrEP trials: the road to success. Clinical Investigation. 2013; 3(3): 295-308. doi:10.4155/cli.12.155

US Centers for Disease Control and Prevention. TDF2 study of pre-exposure prophylaxis (PrEP) among heterosexual men and women in Botswana: Key facts. August 26, 2011. Accessed February 9, 2026. https://stacks.cdc.gov/view/cdc/23283

Pre-exposure prophylaxis, shown to be effective through USAID research: US Agency for International Development. PrEP. Retrieved from: https://www.usaid.gov/global-health/health-areas/hiv-and-aids/technical-areas/prep. Archived at https://web.archive.org/web/20241207024421/ https://www.usaid.gov/global-health/health-areas/hiv-and-aids/technical-areas/prep.

Approaches to prevent mother-to-child HIV transmission, developed with NIH support: NIH-sponsored study identifies superior drug regimen for preventing mother-to-child HIV transmission. Press release. US National Institutes of Health (NIH); November 17, 2014. https://www.nih.gov/news-events/news-releases/nih-sponsored-study-identifies-superior-drug-regimen-preventing-mother-child-hiv-transmission

Approaches to prevent mother-to-child HIV transmission, 62% decline in new infections in children: UNAIDS. Global HIV & AIDS statistics — fact sheet. Accessed February 9, 2026. https://www.unaids.org/en/resources/fact-sheet

Long-acting PrEP options, monthly vaginal ring: Population Council. The dapivirine vaginal ring for HIV prevention. Accessed February 9, 2026. https://popcouncil.org/project/the-dapivirine-vaginal-ring-for-hiv-prevention/ 

Bi-monthly injectable: PrEPWatch. Injectable cabotegravir for PreP. November 18, 2025. Accessed February 26, 2026. https://www.prepwatch.org/products/injectable-cab-for-prep/ 

Twice-yearly injectable: Finzi, D. Breakthrough lenacapavir trial builds on decades of NIH investment in basic science. National Institutes of Health (NIH) Office of AIDS Research. October 2024. Accessed February 9, 2026. https://oar.nih.gov/about/directors-blog/breakthrough-lenacapavir-trial-builds-decades-nih-investment-basic-science 

Child-friendly therapies: Kelley, L. New HIV drug formulation could improve treatment outcomes for children worldwide. University of Colorado Anschutz. August 3, 2023. Accessed February 9, 2026. https://news.cuanschutz.edu/news-stories/new-hiv-drug-formulation-could-improve-treatment-outcomes-for-children-worldwide 

Diagnostic innovations:

Unitaid, World Health Organization. Market and Technology Landscape 2020: HIV Rapid Diagnostic Tests for Self-Testing. Unitaid, World Health Organization; 2020. https://unitaid.org/assets/Unitaid-WHO-HIVST-landscape-report-2020.pdf

Unitaid, World Health Organization. HIV/AIDS Diagnostics Technology Landscape: 5th Edition. Unitaid, World Health Organization; 2015. http://www.unitaid.org/assets/UNITAID_HIV_Nov_2015_Dx_Landscape-1.pdf

Dual/multiplex tests:

World Health Organization Global Sexually Transmitted Infections Programme. Dual HIV/syphilis rapid diagnostics tests. Accessed April 15, 2026. https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/stis/testing-diagnostics/dual-hiv-syphilis-rapid-diagnostic-tests 

WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination goals. Press release. World Health Organization (WHO); July 15, 2025. https://www.who.int/news/item/15-07-2025-who-prequalifies-the-first-triple-diagnostic-test-for-hiv--hepatitis-b-and-syphilis--a-milestone-toward-global-disease-elimination-goals 

WHO announces the development of guidelines on multiplex testing. Press release. World Health Organization (WHO); September 10, 2025. https://www.who.int/news/item/10-09-2025-who-announces-development-of-guidelines-on-multiplex-testing 

Recency tests: Facente SN, Grebe E, Maher AD, et al. Use of HIV recency assays for HIV incidence estimation and other surveillance use cases: systematic review. JMIR Public Health and Surveillance. 2022;8(3):e34410. https://doi.org/10.2196%2F34410

Continued progress is possible, not inevitable

Gates Foundation. Goalkeepers 2025 Report. We Can’t Stop at Almost. Gates Foundation; 2025. https://www.gatesfoundation.org/goalkeepers/report/2025-report/

Key missing tools

AVAC. Prevention options. Accessed February 9, 2026. https://avac.org/prevention-options/ 

Impact Global Health. HIV/AIDS. Accessed February 9, 2026. https://www.impactglobalhealth.org/insights/health-areas/hivaids 

Breakthroughs on the brink

Long-acting biomedical products, once-weekly ARV pill: Study to compare an oral weekly islatravir/lenacapavir regimen with standard of care in virologically suppressed people with HIV-1 (ISLEND-2). ClinicalTrials.gov identifier: NCT06630299. Accessed February 9, 2026. https://www.gileadclinicaltrials.com/study?nctid=NCT06630299 

Long-acting biomedical products, monthly oral PrEP pill: PrEPWatch. MK-8527. Updated February 5, 2026. Accessed February 9, 2026. https://www.prepwatch.org/products/mk-8527/ 

Long-acting biomedical products, three-month vaginal ring:

3-month dapivirine vaginal ring for HIV prevention demonstrates superior drug release compared to 1-month ring. Press release. Population Council; October 7, 2024. https://popcouncil.org/media/3-month-dapivirine-vaginal-ring-for-hiv-prevention-demonstrates-superior-drug-release-compared-to-1-month-ring/ 

PrEPWatch. The dapivirine vaginal ring. Updated February 8, 2026. Accessed February 9, 2026. https://www.prepwatch.org/products/dapivirine-vaginal-ring/

Long-acting biomedical products, once-yearly injectable prevention drug: First clinical data for Gilead’s investigational once-yearly lenacapavir for HIV prevention presented at CROI 2025 and published in The Lancet. Press release. Gilead Sciences, Inc.; March 11, 2025. https://www.gilead.com/news/news-details/2025/first-clinical-data-for-gileads-investigational-once-yearly-lenacapavir-for-hiv-prevention-presented-at-croi-2025-and-published-in-the-lancet 

Long-acting biomedical products, implants: 

Pons-Faudoa F, Di Trani N, Facchi I, et al. Drug-agnostic transcutaneously-refillable subdermal implant for ultra-long-acting delivery of antiretrovirals for HIV prevention. Presented at: HIV Research for Prevention 2024 Conference; 2024; Lima, Peru. Abstract 2159. https://programme2024.hivr4p.org/Abstract/Abstract/?abstractid=2159 

PrEPWatch. Products in Development. Accessed February 9, 2026. https://www.prepwatch.org/products-in-development/ 

Multipurpose prevention products, overall: AVAC. Advocates’ Guide to Multipurpose Prevention Technologies. AVAC; 2021. https://avac.org/resource/advocates-guide-to-multipurpose-prevention-technologies/ 

Multipurpose prevention products, dual prevention pill: PrEPWatch. Dual prevention pill. Updated December 16, 2025. Accessed February 9, 2026. https://www.prepwatch.org/products/dual-prevention-pill/ 

Multipurpose prevention, multipurpose vaginal ring: 

Population Council. The dapivirine-levonorgestrel vaginal ring for HIV prevention and contraception. Accessed February 9, 2026. https://popcouncil.org/project/the-dapivirine-levonorgestrel-vaginal-ring-for-hiv-prevention-and-contraception/ 

Friedland BA, Gundacker H, Achilles SL, et al. Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): implications for multipurpose prevention technology development. PLoS ONE. 2025;20(1): e0312957. https://doi.org/10.1371/journal.pone.0312957 

Multipurpose prevention products, USAID support: US Agency for International Development. Microbicides: New HIV prevention products for women. Retrieved from: https://www.usaid.gov/basic-page/microbicides-new-hiv-prevention-products-women-0.  Archived at: https://web.archive.org/web/20241207024359/https://www.usaid.gov/basic-page/microbicides-new-hiv-prevention-products-women-0 

On-demand prevention option, fast-dissolving vaginal insert: “On-demand” HIV prevention method for women being tested in second early phase trial. Press release. European AIDS Treatment Group; December 10, 2023. https://www.eatg.org/hiv-news/on-demand-hiv-prevention-method-for-women-being-tested-in-second-early-phase-trial/ 

Broadly neutralizing antibodies, trials with NIH support: AVAC. Broadly Neutralizing Antibody Combinations. AVAC; 2025. https://avac.org/resource/infographic/broadly-neutralizing-antibody-combinations-2/ 

Broadly neutralizing antibodies, combination treatment: Callaghan ML. EACS 2025: Novel HIV combo therapy of lenacapavir and 2 bNAbs found effective, well tolerated in Phase 2 trial. European AIDS Treatment Group. October 18, 2025. Accessed February 9, 2026. EACS 2025: Novel HIV combo therapy of lenacapavir and 2 bNAbs found effective, well tolerated in Phase 2 trial

mRNA-based HIV vaccine candidates: Jefferys R. Pipeline Report 2025: HIV Vaccines and Passive Immunization. Treatment Action Group; 2025. https://www.treatmentactiongroup.org/wp-content/uploads/2025/08/Pipeline_HIV_Vaccines_2025.pdf 

mRNA-based HIV vaccine candidates, NIH: A clinical trial to evaluate the safety and immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV trimer mRNA vaccines in healthy, HIV-uninfected adult participants. ClinicalTrials.gov identifier: NCT05217641. Accessed February 9, 2026. https://clinicaltrials.gov/study/NCT05217641#collaborators-and-investigators 

mRNA-based HIV vaccine candidates, DoW: HIV vaccine in HIV-uninfected adults (RV546). ClinicalTrials.gov identifier: NCT04658667. Accessed February 9, 2026. https://clinicaltrials.gov/study/NCT04658667#collaborators-and-investigators 

mRNA-based HIV vaccine candidate, USAID: Two HIV vaccine trials show proof of concept for pathway to broadly neutralizing antibodies. Press release. IAVI and Scripps Research; May 15, 2025. https://www.iavi.org/press-release/two-hiv-vaccine-trials-show-proof-of-concept-for-pathway-to-broadly-neutralizing-antibodies/ 

New vaccine strategies:

AVAC. Vaccines for prevention. Accessed February 9, 2026. https://avac.org/prevention-option/vaccines/ 

IAVI. HIV vaccines. Accessed February 9, 2026. https://www.iavi.org/our-work/hiv-vaccines/ 

Phase 1 clinical trial of HIV vaccine starts in Africa to evaluate immune responses to highly networked HIV T-cell epitopes. Press release. IAVI; August 4, 2025. https://www.iavi.org/press-release/phase-1-clinical-trial-of-hiv-vaccine-starts-in-africa/ 

US National Institutes of Health. Clinical trial of HIV vaccine begins in United States and South Africa. September 20, 2023. Accessed February 9, 2026. https://www.nih.gov/news-events/news-releases/clinical-trial-hiv-vaccine-begins-united-states-south-africa 

To investigate safety, reactogenicity and immunogenicity of VIR-1388 compared with placebo in participants without HIV. ClinicalTrials.gov identifier: NCT05854381. https://clinicaltrials.gov/study/NCT05854381 

Child-focused HIV technologies, experimental HIV vaccine: Weill Cornell Medicine. New NIH grant supports development of experimental pediatric HIV vaccine. News Medical. September 18, 2025. Accessed February 9, 2026. https://www.news-medical.net/news/20250918/New-NIH-grant-supports-development-of-experimental-pediatric-HIV-vaccine.aspx 

Child-focused HIV technologies, child-friendly drug for infants: Cressey TR, Salvadori N, Rabie H, et al. Single doses of pediatric dolutegravir dispersible tablets in neonates support multidosing: PETITE-Dolutegravir study. Journal of Acquired Immune Deficiency Syndromes. 2025l99(2):195-201. doi:10.1097/QAI.0000000000003652 

Point-of-care HIV viral load testing technologies: NIH announces awards to advance tech for HIV viral load detection. Press release. US National Institutes of Health (NIH) National institute of Biomedical Imaging and Bioengineering; December 19, 2024. https://www.nibib.nih.gov/news-events/newsroom/nih-announces-awards-advance-tech-hiv-viral-load-detection 

Ten patients cured/in remission: 

Cox D. Whatever happened to ... the race to cure HIV? There's promising news. NPR. August 25, 2025. Accessed February 9, 2026. https://www.npr.org/sections/goats-and-soda/2025/08/25/g-s1-84393/whatever-happened-to-the-race-to-cure-hiv-theres-promising-news 

Jefferys R. Pipeline Report 2025: Research Toward a Cure and Immune-Based Therapies. Treatment Action Group; 2025. https://www.treatmentactiongroup.org/wp-content/uploads/2025/08/Pipeline_Cure_IBT_2025.pdf

US government investment in HIV/AIDS R&D

G-FINDER data portal. Policy Cures Research; 2026. Accessed February 2, 2026. https://gfinderdata.policycuresresearch.org/ 

US government R&D efforts

KFF. US Federal Funding for HIV/AIDS: Trends Over Time. KFF; 2024. https://www.kff.org/hivaids/fact-sheet/u-s-federal-funding-for-hivaids-trends-over-time/ 

Michaud J, Moss K, Kates J. The US Department of Defense and Global Health. KFF; 2012. https://www.kff.org/global-health-policy/report/the-u-s-department-of-defense-global/ 

US Food and Drug Administration. President's Emergency Plan for AIDS Relief (PEPFAR). Updated May 15, 2022. Accessed February 9, 2026. https://www.fda.gov/international-programs/presidents-emergency-plan-aids-relief-pepfar 

Chmiola M, Long A. USAID’s latest global health R&D report offers glimpse of progress now at risk. Global Health Technologies Coalition. May 5, 2025. Accessed February 26, 2026. https://www.ghtcoalition.org/blog/fy-24-usaid-global-health-r-d-report-analysis 

PEPFAR’s support of American innovation to reach up to 2 million people by 2028 with breakthrough HIV drug lenacapavir. Press release. US Department of State; September 4, 2025. https://www.state.gov/releases/the-united-states-presidents-emergency-plan-for-aids-relief/2025/09/pepfars-support-of-american-innovation-to-reach-up-to-2-million-people-by-2028-with-breakthrough-hiv-drug-lenacapavir/ 

Pigott T. Advancing the America First Global Health Strategy through landmark bilateral global health MOUs with Botswana, Madagascar, Sierra Leone, and Ethiopia. Press statement. US Department of State; December 23, 2025. https://www.state.gov/releases/office-of-the-spokesperson/2025/12/advancing-the-america-first-global-health-strategy-through-landmark-bilateral-global-health-mous/ 

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