A Clinical Trial to Evaluate an Investigational Medicine for HIV-1 Preexposure Prophylaxis (PrEP)

Sponsored by Merck

What is HIV?

HIV (human immunodeficiency virus) is a virus that affects the body’s immune system, making it harder to fight infections.¹ Without treatment, HIV can lead to AIDS.²  About 1.2 million people in the U.S. live with HIV, and about 13% of them don’t know it.³ People have a higher chance of contracting HIV if they have sex with someone who has HIV or share needles to inject drugs.⁴

How does HIV affect different communities? 

Anyone can get HIV—it does not depend on race, gender or sexual orientation.⁵ But some communities have higher rates of new infections than others.⁶ 

Black adults make up almost 40% (4 out of 10) of new HIV infections, even though they are only about 12% (about 1 out of 10) of the U.S. population.⁶ Black adults are also about eight times more likely to be diagnosed with HIV than white adults in the U.S.⁷  Also, gay, bisexual and other men who have sex with men (including teens and adults) accounted for about 67% (almost 7 out of 10) of new HIV diagnoses in the U.S. in 2022.⁸ 

These differences are not because of the people themselves. They happen because of bigger social and structural issues, such as limited access to healthcare and stigma around who gets HIV.⁹ 

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“Despite being affected by HIV more than other groups, Black people remain underrepresented in clinical research,” said Alana Miller, Clinical Trial Diversity Program Lead at Merck. “Diseases can impact people differently based on their age, gender, weight, race, ethnicity, sexual orientation and other factors. It’s important all people participate in clinical trials to help researchers understand how investigational medicines work across populations.”

A clinical trial to evaluate an investigational medicine for HIV-1 Preexposure Prophylaxis (PrEP)

You may have heard of “PrEP,” which stands for pre-exposure prophylaxis. PrEP is a type of medicine that is taken before being exposed to HIV to help lower the chances of being infected with the virus. 

Merck is sponsoring a Phase 3 clinical trial (NCT07044297) to evaluate an investigational monthly Prep medicine. The goal is to compare the investigational medicine to an approved once daily PrEP medicine to assess the investigational medicine’s safety, how it functions in the body and any side effects (tolerability).  

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Who can join?

People may be able to take part in the trial if they are at least 16 years of age and: 

• Do not have HIV
• Are a cisgender man (assigned male at birth and identify as male), transgender woman (assigned male at birth and identify as female), transgender man (assigned female at birth and identify as male), or gender nonbinary (assigned any gender at birth and do not identify as exclusively male or female)

There are additional eligibility criteria, which the study team can discuss with you. There may be risks related to participating in this clinical research study.

What else should I know about this trial?

If you are eligible, you can decide whether to join or not. If you join, you can choose to leave at any time, for any reason. The trial staff will keep your personal information private. They will also discuss the possible risks and benefits of participation with you, and you can ask questions before agreeing to participate.

While you may or may not directly benefit from being in this clinical trial, you may help researchers learn more about the investigational medicine being studied. 

Learn more about this clinical trial

If you think you or a loved one may be eligible for this trial, visit merckclinicaltrials.com/HIVtrial and talk with your doctor. 

References

1. HIV.gov. What are HIV and AIDS? Updated April 13, 2026. Accessed May 2026. https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/what-are-hiv-and-aids 
2. Centers for Disease Control and Prevention. About HIV. Updated January 14, 2025. Accessed May 2026. https://www.cdc.gov/hiv/about/index.html 
3. HIV.gov. U.S. statistics. Updated February 25, 2026. Accessed May 2026. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics 
4. HIV.gov. How is HIV transmitted? Updated February 25, 2026. Accessed May 2026. https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/how-is-hiv-transmitted 
5. HIV.gov. Who is at risk for HIV? Accessed May 2026. https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/who-is-at-risk-for-hiv 
6. amfAR. HIV/AIDS in the U.S. Updated February 2026. Accessed May 2026. https://www.amfar.org/about-hiv-aids/hiv-aids-in-the-us/ 
7. Laurencin CT, Murdock CJ, Laurencin L, Christensen DM. HIV/AIDS and the African-American Community 2018: a Decade Call to Action. J Racial Ethn Health Disparities. 2018;5(3):449-458. doi: 10.1007/s40615-018-0491-0
8. HIVinfo.NIH.gov. HIV and gay and bisexual men. Last reviewed March 20, 2026. Accessed May 2026. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-and-gay-and-bisexual-men 
9. Centers for Disease Control and Prevention. Fast facts: HIV in the US by race and ethnicity. Updated May 21, 2024. Accessed May 2026. https://www.cdc.gov/hiv/data-research/facts-stats/race-ethnicity.html