Active not recruitingPHASE2INTERVENTIONAL

Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

This research is investigating a new medication called lenacapavir, which could potentially be taken as an injection just twice a year, as well as a daily pill version. It is being compared to a currently available daily tablet, emtricitabine/tenofovir disoproxil fumarate (known as F/TDF or Truvada). The main purpose is to see how effectively these drugs can prevent HIV infection in people who could benefit from this protection. Researchers are also checking how safe these medications are, how people feel about using the injections compared to daily tablets, and how the new drug moves through the body. This is a Phase 2 study, meaning it’s still in the earlier stages of human testing to gather more information on safety and effectiveness.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Gilead Sciences

Enrolment target

268

Start

07 Oct 2024

Estimated completion

01 Nov 2028

Pre-Exposure Prophylaxis of HIV Infection

What is this study about?

This study is about finding new ways to prevent HIV infection in people who are at a higher risk of getting it. It focuses on a new medication called lenacapavir, which is being tested in two forms: an injection given only twice a year, and a daily pill. These are being compared to an existing and effective daily pill called F/TDF (also known as Truvada), which is already used for HIV prevention.

The main goals of this research are to see if lenacapavir, in both its injection and tablet forms, works as well as F/TDF in consistently preventing HIV. Researchers will also be closely watching for any side effects to make sure the drugs are safe. They want to understand how people feel about taking an injection twice a year compared to a daily pill, which is important for people to stick with their treatment. Finally, the study will also look at how lenacapavir acts within the body to understand its effects better.

Finding new prevention options is really important because it can give more choices to people to protect themselves from HIV in a way that suits their lifestyle. A twice-yearly injection, if proven safe and effective, could be a very convenient option for many, potentially making it easier to stay protected compared to a daily pill. This study is an important step in developing these potential new tools for HIV prevention.

Key takeaways

Tests a new twice-yearly injection and daily pill for HIV prevention.
Compares these new options to a standard daily prevention pill (Truvada).
Focuses on safety, effectiveness, and how easy the treatments are to use.
Aims to find more convenient ways for people to protect themselves from HIV.
It's an earlier stage (Phase 2) study in human volunteers.

Who may be eligible?

To join this study, you need to be at least 18 years old. It's open to men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people. A key part of qualifying is having a higher chance of getting HIV. This means things like having unprotected sex with two or more partners in the last six months, having certain STIs recently, or having unprotected sex with a partner living with HIV whose viral load isn't controlled.

You must also have negative HIV test results at the start of the study, confirming you don't already have HIV. Your kidneys need to be working well, which will be checked with a blood test. You should be able to understand what the study involves and agree to take part by signing a consent form.

You can't join if you're already taking other medication to prevent HIV (PrEP) and have been using it in the last four weeks. You also shouldn't be in another clinical study or have a known allergy to the medications being tested. The study doesn't ask you to stop any current PrEP to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you feel you are at a higher risk of getting HIV?
Do you not currently have HIV?
Are your kidneys generally healthy?
Are you able to understand and sign a consent form for research?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the new drug lenacapavir (as an injection or a tablet) or the existing daily tablet, F/TDF. You will have regular visits to the clinic where you'll receive your medication, have various assessments, and undergo tests to monitor your health and how the medication is working. These tests will include blood tests to check for HIV and review your general health, as well as checking how the study drug is moving through your body. The study will also involve discussing your experiences with the treatment, especially if you're receiving the injections, to understand how acceptable it is. The total duration of the study, including follow-up, will be explained to you in detail if you are considering joining. You will receive all necessary care related to the study medications and monitoring throughout your participation.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as gaining access to new forms of HIV prevention that might be more convenient than current options, and receiving close medical monitoring throughout the study. However, like all medications, there are potential risks, including side effects from the study drugs – a full list will be explained to you. There's also the chance the new medication might not work as well as expected, or that you might feel uncomfortable with some of the tests or procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care, and your doctors will fully support your decision.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hopital Avicenne
Verified postcode
Bobigny, France
Hopital Europeen Marseille
Verified postcode
Marseille, France
CHU Nice Archet
Verified postcode
Nice, France
Hopital Saint Louis - Assistance Publique des Hopitaux de Paris
Verified postcode
Paris, France
APHP Hopital Saint-Antoine
Verified postcode
Paris, France
APHP Bichat Claude-Bernard Hospital
Verified postcode
Paris, France
University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital
Verified postcode
Birmingham, United Kingdom
Clinical Research Facility, University Hospitals Sussex NHS Foundation Trust
Verified postcode
Brighton, United Kingdom
Axess Sexual Health, Liverpool University Hospitals NHS Trust
Verified postcode
Liverpool, United Kingdom
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, Barts Health NHS Trust
Verified postcode
London, United Kingdom
Homerton Healthcare NHS Foundation Trust, Homerton University Hospital
Verified postcode
London, United Kingdom
Caldecot Centre, Kings College Hospital, Kings College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is PrEP?

PrEP stands for Pre-Exposure Prophylaxis. It's a way for people who don't have HIV but are at a higher risk of getting it, to take medication to prevent infection.

What is lenacapavir?

Lenacapavir is a new medicine being tested to see if it can prevent HIV. In this study, it's being given as an injection (twice a year) or a daily pill.

What is F/TDF (Truvada)?

F/TDF, also known as Truvada, is a daily pill that is already approved and widely used as PrEP to prevent HIV infection.

Will I know which treatment I'm getting?

Sometimes in studies like this, participants don't know which treatment they are receiving until the study is over, to keep the results fair. This will be fully explained before you agree to take part.

How long will the study last?

The full duration of your involvement, including all visits and follow-up, will be made clear to you by the study team if you are eligible and considering participation.