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HIV Prevention

For decades, Gilead has been at the forefront of the HIV epidemic, having developed the first pre-exposure prophylaxis (PrEP) medication to prevent HIV infection. Now, with the help of clinical trial volunteers, we continue our quest to develop new effective HIV prevention options for everyone who may need or want PrEP.

hiv prevention

Recruiting Trials

purpose 3

PURPOSE 3

A phase 2 study of a twice yearly, long-acting injection of Lenacapavir for PrEP in cisgender women in the U.S.
purpose 4

PURPOSE 4

A phase 2 study of a twice yearly, long-acting injection of Lenacapavir for PrEP in people who inject drugs in the U.S.

The HIV Landscape

Where we stand with HIV infection
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32,100

In 2021, there were 32,100 estimated new HIV infections in the U.S., a 12% decline since 2017.
Source: CDC.gov
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1.2M

Approximately 1.2 million people in the U.S. have HIV. About 13 percent of them don’t know they have it.
Source: HIV.gov
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1 in 7

Between 2006-2017, 1 in 7 transgender women in the U.S. were living with HIV, with Black and Latine transgender women impacted at significantly higher rates.
Source: CDC.gov
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52%

In 2021, more than half (52%) of new HIV infections in the U.S. were in the U.S. South.
Source: CDC.gov

Gilead’s Focus

Our Commitment to HIV Prevention

Learn About PrEP and Ongoing Studies

  • PrEP (pre-exposure prophylaxis) is the routine use of prescription medicine before a person is exposed to HIV, to reduce their chances of getting it.
  • Per the CDC, when taken as prescribed, PrEP reduces the risk of getting HIV through sex by 99%, and through injection drug use by at least 74%. However, not everyone who could benefit from PrEP is using PrEP. Many individuals, especially persons of color, face many individual, social, and structural barriers to accessing PrEP and other sexual health services.
  • PrEP medication does not protect against other sexually transmitted infections (STIs), so consistent condom use is important.
Learn More
Learn About PrEP

Partnering for Inclusion in Clinical Trials

“Ever since the beginning of the HIV epidemic, we’ve known that the science is better when everyone has a seat at the table,” says Moupali Das, Gilead’s HIV Prevention Clinical Lead. For that reason, Gilead’s PURPOSE clinical trials engage Global Community Advisory Groups (G-CAGs) for their input on the community, cultural considerations, and more. G-CAG members were selected based on their significant contributions to the HIV space in their communities, in advocacy, and experience with clinical development work.

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Paving the Way Forward for Inclusive Clinical Trials

Beyond Clinical Trials

HIV among women
Aiming to Reduce HIV Among Young Women and Girls
Girls and young women account for 71% of new HIV infections among adolescents in sub-Saharan Africa. Through the DREAMS initiative, which is led by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), Gilead provides funding for PrEP with the goal of helping young women stay HIV-free. In its first year, DREAMS reached one million adolescent girls and young women and saw a 25-40% reduction in new HIV diagnoses in 65% of DREAMS districts.
 
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Igniting Change

Gilead supports the work of grassroots organizations that are helping address a collective mission and advance education in the HIV space.

Some of Gilead’s key HIV partnerships and initiatives

Community Voices

Meet the people and programs dedicated to improving HIV care

advancing health

Black Women and the HIV Epidemic

“Over the years, Gilead has thoughtfully and boldly focused on communities with the greatest unmet needs, and women and girls – in particular, Black women and girls – are always at the top of the list.” - Deborah Telman, Executive Vice President, Corporate Affairs and General Counsel at Gilead.
helping address

HIV Epidemic in the US South

The Gilead COMPASS Initiative®, is a 10-year, $100+ million commitment to addressing the HIV epidemic in the Southern United States. In its fifth year, COMPASS has worked closely with and provided funding to nearly 400 community-based organizations across 16 states in the U.S South that address health inequities and other barriers to care.

More HIV Prevention Trials

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Explore Our Other HIV Research Areas

hiv treatment cure

HIV Treatment

We're focused on advancing a pipeline of investigational treatment options to create longer lasting, increasingly effective HIV treatments. Learn more about HIV treatment clinical trials.
Hiv in Children

Children with HIV

An estimated 1.7 million children under the age of 15 live with HIV. Gilead is deeply committed to the discovery and development of urgently needed, age-appropriate treatments for children living with HIV. Learn more about Gilead’s work in Pediatric HIV research.

Your Questions Answered

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

YOUR QUESTIONS ANSWERED

FAQ Topic:
ALL Clinical Trial Basics Safety and Security Trial Terms Defined The Clinical Trial

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

All trials have different timelines due to various factors, such as the trial phase, study design, treatment duration or health condition being studied. During the consent process before enrolling, the research team will explain the specifics about the trial.
Due to the many differences in insurance plans across the country, coverage in clinical trials can vary. You will learn more about your options during pre-screening.
If you are living with a medical condition, joining a clinical trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future. Healthy volunteers in trials contribute to this medical progress as well by helping understand the effect of the potential treatment and any safety concerns.
As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.
Yes, participants are volunteers and may withdraw from a clinical trial at any time.
A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and research team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if no approved intervention is available.
"Standard of care" is an intervention already approved for a specific health condition that is available publicly. Interventions in a clinical trial are still being tested to ensure safety and effectiveness.
Some clinical trials are designed to be "double blind" so both participants and researchers are unaware of which treatment group participants are assigned to. This prevents bias from affecting clinical trial data.
Your informed consent is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.
Under FDA regulations, an Institutional Review Board (IRB) is a group that has been formally designated to review and monitor research at a hospital or institution involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research.
Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.
After your participation ends, the study may continue for months or years. Once final results from all participants are compiled and analyzed, they are often published publicly. Clinical study report (CSR) synopses and plain language summaries (PLSs) may be made available for certain studies. Check with your clinical trial site or send an email to [email protected] to learn more.
There are a wide variety of professionals involved with any clinical trial, all of whom are vital to ensuring safety and success. The principal investigator, or PI, leads the trial and directs the team of doctors, nurses and other healthcare workers. The clinical trial coordinator manages day-to-day activities and is the main contact for participants. Many clinical trials also have an independent Data and Safety Monitoring Board (DSMB) who periodically reviews data to ensure participant safety, and sometimes effectiveness.
If you don’t qualify because you don’t meet the trial criteria, consider discussing other options with your healthcare provider or the patient’s physician would need to submit a managed access request based on the eligibility. Click here to learn more.