Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF after Discontinuing Injectable CAB + RPV

This new study is for adults living with HIV. It's looking at a one-pill treatment called Biktarvy (which combines three medicines: BIC, FTC, and TAF). Participants in the study will have recently stopped taking a different injectable HIV treatment that combined two medicines (CAB and RPV). The main aim is to check if Biktarvy is safe when used this way. Researchers will be looking for any serious side effects or changes in blood test results in the first 12 weeks. They will also study how well the body uses Biktarvy over time and if it continues to keep the amount of HIV in the blood very low. This study helps doctors understand the best ways to manage HIV and ensure treatments are as safe and effective as possible for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Gilead Sciences Inc.

Enrolment target

Start

07 Feb 2024

HIV-1 infection

What is this study about?

This study is looking at a medicine called Biktarvy, which is a single pill taken by mouth once a day. It contains three different medicines that work together to treat HIV. The study's main goal is to see how safe Biktarvy is and how well it works for adults who have recently stopped taking a different type of HIV treatment that was given by injection. This injectable treatment combined two medicines.

Researchers want to understand if switching from the injectable treatment to Biktarvy is a good option. They will closely watch for any serious side effects and check blood test results to make sure everything is okay. They will also measure how much of the Biktarvy medicine is in the body over time, which helps them understand how the body uses it.

Another important part of the study is to see if Biktarvy continues to keep the amount of HIV in a person's blood very low, which is key to staying healthy with HIV. They will also look at how satisfied people are with their HIV treatment when taking Biktarvy. This information helps doctors make the best treatment choices for people living with HIV, making sure the medicines are both effective and easy to live with.

Key takeaways

This study is for adults with HIV-1 who are stopping injectable treatment.
It's about taking a daily pill called Biktarvy instead of injections.
The main focus is checking the safety and how well Biktarvy controls HIV.
Participants will have regular clinic visits and blood tests.
The study lasts at least 6 months.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older. It is open to both men and women.

To join, you must be living with HIV-1 infection. You would also need to have recently stopped, or be about to stop, your current injectable HIV treatment that combines two specific medicines (cabotegravir and rilpivirine).

There will be other health checks and requirements to make sure the study is right for you and safe for everyone involved. Your doctor can discuss all the details with you.

Quick self-check

Are you 18 years old or older?
Do you have HIV-1 infection?
Are you currently being treated with the injectable HIV medicines cabotegravir and rilpivirine, or about to stop them?
Are you able to take a daily tablet by mouth?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would start taking a daily Biktarvy tablet. Over several months, you'd have regular visits to the clinic. During these visits, the study team would take blood samples to check for side effects and measure the medicine levels in your body. They would also monitor your overall health and how well the treatment is working to control your HIV. You might also fill out questionnaires about how you feel about your treatment. The study would last at least 24 weeks (about 6 months), with possible longer follow-up.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a well-established HIV treatment and close medical monitoring. However, there are also potential risks, including side effects from the medication, which would be carefully monitored. Blood tests and clinic visits might also be inconvenient. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is Biktarvy?

Biktarvy is a single tablet that combines three medicines to treat HIV. You take it once a day by mouth.

Why is this study being done?

The study aims to see how safe and effective Biktarvy is for people switching from a different injectable HIV treatment.

Who can join this study?

Adults aged 18 or over who are living with HIV and are stopping a specific injectable HIV treatment.

How long will the study last?

The main part of the study will last for at least 24 weeks, which is about 6 months, and possibly longer.

What kind of tests will I have?

You will have regular blood tests to check how your body is reacting to the medicine and how well it's working.