Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

DTG/3TC vs BIC/FTC/TAF maintenance therapy in people living with HIV: an open-label randomized clinical trial

This important study is looking into how well two different medications, Biktarvy and Dovato, work for people living with HIV. Both are established treatments, and the main goal is to see if Dovato is just as effective as Biktarvy at keeping the amount of HIV in the blood very low (under 50 copies per milliliter). This is crucial for maintaining good health and preventing the virus from causing harm. Essentially, the researchers want to confirm that switching to or using either of these treatments can keep the virus suppressed. The study is open to adults aged 18 and over, and both men and women can take part. It's a way to help ensure people with HIV have the best treatment options available.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Fundacion Seimc Gesida

Enrolment target

555

Start

05 Sep 2024

HIV

What is this study about?

This study is comparing two common treatments for HIV: Biktarvy and Dovato. If you're living with HIV, you might already be familiar with one or both of these. The main purpose of the study is to see if Dovato is just as good as Biktarvy at keeping the amount of HIV in your blood very low. This is called 'viral suppression' and it's really important for your health.

Keeping the HIV virus suppressed means there's so little of it in your body that it can't harm your immune system or be passed on to others through sex. Both Biktarvy and Dovato are known to be effective, but this research wants to scientifically confirm if they perform similarly in keeping the virus undetectable over time. Findings from this study could help doctors and patients make informed choices about treatment.

By comparing these two medicines, researchers hope to give people with HIV more options and confidence in their treatment plans. This type of research helps improve the care and quality of life for everyone living with HIV.

Key takeaways

Compares two proven HIV treatments: Biktarvy and Dovato.
Aims to confirm if Dovato is as effective as Biktarvy in keeping HIV levels very low.
Helps doctors and patients make informed treatment choices.
Open to adults (18+) living with HIV, regardless of gender.
Involves regular health check-ups and monitoring.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can potentially join.

Anyone, regardless of whether they are male or female, can take part. The study is looking for a broad range of people living with HIV to ensure the results apply to many different individuals.

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?
Are you currently living with HIV?
Are you comfortable with the idea of being randomly assigned to one of two treatments?
Are you able to attend regular clinic appointments for check-ups and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the Biktarvy medication or the Dovato medication. This means a computer decides which treatment you get, much like flipping a coin, to ensure fairness and accuracy in the study results.

Throughout the study, you would have regular appointments at the clinic. During these visits, the study team would check your health, take blood samples to measure your HIV levels, and make sure the medication is working well for you. They would also monitor for any side effects. You would receive your study medication at these visits. The total length of your participation would be explained fully by the study team, but typically, these types of studies involve regular follow-up over an extended period.

Potential risks and benefits

Potential benefits of joining this study include receiving advanced HIV medication and regular, thorough health monitoring by a dedicated medical team. This close oversight can be reassuring. There are always potential risks with any medication; these can include experiencing side effects specific to Biktarvy or Dovato, which the study team would explain in detail. While the treatments are standard care, there's a chance the assigned medication might not work as well for you as another option. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is the main goal of this study?

The main goal is to compare two HIV medications, Biktarvy and Dovato, to see if they are equally effective at keeping the HIV virus levels very low in the body.

Who can take part in this study?

Adults aged 18 years and older, both male and female, who are living with HIV.

Will I get to choose which medicine I receive?

No, you will be randomly assigned to receive either Biktarvy or Dovato, similar to drawing straws, to make the study fair.

What does a 'low' amount of HIV mean?

It means having less than 50 copies of the HIV virus per milliliter of blood, which is often called 'undetectable' and is key for good health.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your usual medical care.