AuthorisedPhase II and Phase III (Integrated)Interventional

An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination with Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

Most people with HIV take a tablet every day to keep the virus under control and protect their immune system. While daily pills work very well, taking a pill every day can be difficult or stressful for some people. This clinical trial is testing a new, long-acting injectable treatment for adults who have recently been diagnosed with HIV-1 and have never taken HIV medication before. Researchers are comparing an injection combining two medicines (GS-3242 and lenacapavir) with Biktarvy, which is a common daily tablet. The trial will see if the long-acting injections can keep the virus at very low, undetectable levels just as effectively and safely as the daily tablet. It also looks at side effects and how the injections affect immune health over time. Taking part helps scientists find out if long-acting injections could offer people living with HIV more freedom and choice.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Gilead Sciences Inc.

Enrolment target

185

Start

09 Oct 2026

human immunodeficiency virus type 1 (HIV-1)

What is this study about?

Human immunodeficiency virus (HIV) weakens the body's immune system by attacking white blood cells called CD4 cells. Thanks to modern medicine, people living with HIV can lead long, healthy lives. Standard treatment usually involves taking an anti-HIV tablet every single day. When taken regularly, these tablets reduce the amount of virus in the blood to undetectable levels, meaning the virus cannot harm the body or be passed on to sexual partners.

However, remembering to take a pill every day can be challenging for some people. This study explores an alternative approach: long-acting injections. The trial compares a combination of two injectable medicines—called GS-3242 and lenacapavir—against a standard daily tablet called Biktarvy. Lenacapavir works by interfering with the shell of the virus, while GS-3242 is an experimental medicine designed to stop the virus from multiplying.

The main goal is to find out if receiving injections at scheduled intervals works just as well at keeping the virus suppressed as taking a daily pill. Researchers will monitor participants' viral levels, check their immune system health by counting CD4 cells, and carefully record any side effects. If successful, this research could help offer people living with HIV more flexibility in their daily lives.

Key takeaways

The study tests a new long-acting injection against a standard daily tablet for HIV-1.
It is for adults aged 18 and over who have never taken HIV treatment before.
Participants are randomly assigned to either the injectable medicines or the daily pill.
The trial measures whether the injections keep the virus undetectable just as effectively as tablets.
Taking part involves regular clinic visits for blood tests and health checks over up to two years.

Who may be eligible?

This trial is open to adults aged 18 and older of any sex or gender who have been diagnosed with HIV-1. A key requirement is that participants must be 'treatment-naive'. This means you have not taken regular medications for HIV in the past.

Before joining, the study team will carry out health checks and blood tests. These checks ensure that the trial treatments are safe for you and that your strain of the virus does not have resistance to the medicines being tested. You will also need to be able to attend regular clinic visits and follow the study schedule.

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.

I am 18 years old or older.
I have been diagnosed with HIV-1.
I have never taken long-term HIV treatment before.
I am able to attend regular hospital or clinic appointments for up to two years.
I am happy to receive either a daily tablet or regular injections.

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be placed into a treatment group by chance (randomly). You will either receive the new long-acting injections (GS-3242 and lenacapavir) or take the daily Biktarvy tablet. Injections may begin with tablets for a short time before moving to regular injections given by the clinic staff. The study lasts for up to two years (around 104 weeks). During this time, you will visit the hospital or clinic regularly for check-ups. At these visits, doctors will test your blood to measure your viral load and CD4 immune cells, check your general health, and ask how you are feeling. All study medicines, tests, and care are provided at no cost to you.

Potential risks and benefits

Taking part may help keep your HIV under control while giving you access to new treatments and regular medical check-ups. However, there are potential risks. Like all medications, the study drugs can cause side effects. Common issues may include soreness, redness, or swelling where the injection is given, as well as headaches or an upset stomach. Because GS-3242 is still being tested, there might also be unknown side effects. Your health will be monitored very closely throughout the trial. Joining is completely voluntary, and you can leave the study at any time without it affecting your standard NHS care.

Locations (5)

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

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Unverified
Portugal
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Unverified
Poland
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Unverified
Germany
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Unverified
Romania
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Unverified
Spain

Common questions

Will I definitely receive the injectable treatment?

No. A computer assigns you by chance to receive either the injections or the daily tablet. Both groups receive active, working HIV treatment; no one receives an inactive dummy treatment (placebo).

How often would I need to receive the injections?

The exact schedule depends on which study group you are in, but long-acting injections are typically given every few weeks or months at the clinic by a trained nurse or doctor.

Can the virus still become undetectable on these treatments?

Yes. The main goal of both the injections and the daily tablet is to bring the virus down to undetectable levels (fewer than 50 copies per millilitre of blood).

What happens if the treatment is not working for me?

Your blood will be tested regularly. If the study treatment is not keeping the virus suppressed, the doctors will change your medication to an approved standard treatment straight away.

Does taking part cost anything?

No. All study visits, tests, and medications are provided free of charge, and trial sites often help cover your travel costs.