Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Phase IV, Randomized, Multicenter, Double-Blind Clinical Trial Designed to Evaluate the Safety and Appropriateness of Switching from DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control, and Neuropsychiatric Vulnerabilities: MIND Study

This research study, called the MIND Study, is looking into how changing HIV medication affects people who have HIV and are also experiencing some mental health or brain-related symptoms, like issues with mood, memory, or sleep. The study is for adults whose current HIV treatment is working well. Researchers want to compare two common HIV medications, Dovato and Biktarvy. They are particularly interested in seeing if switching from Dovato to Biktarvy is safe and helpful in managing or reducing these brain-related symptoms. The study will carefully monitor participants for any side effects and how they feel overall after changing their medication.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacion Seimc Gesida

Enrolment target

Start

13 May 2024

HIV

What is this study about?

Imagine you're taking medicine for HIV, and it's doing a great job keeping the virus under control. However, you might also be dealing with other symptoms, perhaps related to your mood, how clearly you think, or your sleep patterns. This study, called the MIND Study, is designed to look closely at these kinds of symptoms when people with HIV switch their medication.

The main goal of this study is to see if changing from one common HIV medicine (Dovato) to another (Biktarvy) makes a difference to these brain-related symptoms. The researchers will be checking to see if the new medicine is safe and if it helps people feel better or reduces any unwanted effects on their mood, thinking, or sleep. They want to understand if one treatment might be better than the other for people who have HIV and these specific concerns.

This is a 'Phase IV' study, which means the medicines involved are already approved and widely used. The study will involve many people in different centres and will be 'double-blind', meaning neither you nor your doctor will know which medicine you're taking, until after the study is over. This helps to make sure the results are as fair and accurate as possible.

Key takeaways

The study helps understand how changing HIV medication affects mood, thinking, and sleep.
It's for adults with HIV whose current treatment is working well.
It compares two existing HIV medicines: Dovato and Biktarvy.
'Double-blind' means neither you nor your doctor will know which medicine you're taking.
Participation involves taking medication and attending regular health checks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult volunteers who are at least 18 years old. Both men and women can take part.

You would be a good fit if you have HIV and your current treatment is working well, meaning the virus is under control. The study is specifically for people who might also be experiencing some brain-related symptoms, such as problems with mood, memory, or sleep.

It's important that you discuss your full medical history with the study team to make sure this study is right for you. They will go through a detailed checklist to confirm if you meet all the requirements to join.

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?
Have you been diagnosed with HIV?
Is your current HIV treatment effectively controlling the virus?
Are you experiencing any changes in your mood, memory, concentration, or sleep?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either Biktarvy or Dovato tablets to take regularly. You won't know which one you are taking, and neither will your doctor, to ensure fair results. You'll need to attend regular appointments at the study clinic. During these visits, the study team will carry out health checks, ask you questions about how you're feeling, and do tests to monitor your HIV and any potential side effects. These assessments will focus on how your mood, thinking, and sleep are affected. The total duration of your participation in the study, including the number of visits and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as contributing to a better understanding of HIV treatment and how it affects people's overall well-being. You will also receive careful medical monitoring throughout the study. However, there are potential risks, including side effects from the medication, which will be carefully monitored. 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 does 'double-blind' mean?

It means neither you nor your doctor will know which study medicine you are taking. This helps ensure the study results are fair and unbiased.

What kind of 'neuropsychiatric vulnerabilities' are they looking at?

This refers to things like changes in mood, memory, concentration, or sleep patterns that some people with HIV might experience.

Are the medications used new or experimental?

No, both Biktarvy and Dovato are approved and commonly used HIV medications. This study is looking at how switching between them affects certain symptoms.

Will I really be monitored closely?

Yes, if you participate, you will have regular medical appointments and tests to check your health and how you are responding to the medication, including any side effects.

Can I stop participating if I want to?

Absolutely. You are free to withdraw from the study at any time, for any reason, and your decision will not affect your ongoing medical care.