Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial.
This research study is for people living with HIV who are currently on treatment. It aims to compare two types of commonly used HIV medication regimens: one with two drugs (2DR) and another with three drugs (3DR). Specifically, it's looking at Biktarvy (a 3-drug treatment) and Dovato (a 2-drug treatment). The main goal is to understand how these treatments affect the amount of HIV that remains 'hidden' in the body's immune cells over time. Researchers will also be checking various health markers, including other viral levels, immune system health, and overall well-being, over several years. This study hopes to provide valuable information to help doctors and patients make informed decisions about HIV treatment.
At a glance
What is this study about?
This study is designed to learn more about two types of HIV treatments: Biktarvy and Dovato. People living with HIV usually take a combination of medicines to keep the virus under control. Biktarvy is a treatment that uses three different drugs combined into one pill. Dovato is a newer treatment that uses two different drugs in one pill. Both are very effective at treating HIV.
The main aim of this study is to compare these two approaches. Researchers want to understand if a 2-drug treatment like Dovato works just as well as a 3-drug treatment like Biktarvy in the long run. They are particularly interested in seeing how much of the HIV virus remains 'hidden' but intact within certain immune cells (called CD4 cells) in the body. Although current treatments can make the virus undetectable in blood tests, some virus can still be present in these cells, and understanding this is important for future research.
Over several years, the study will also look at many other aspects of health. This includes monitoring the virus in different ways, checking how the immune system is working, looking at general health markers like metabolism, and even assessing risks for heart and blood vessel problems. By gathering all this information, the study hopes to provide valuable insights that could help improve HIV care and guide treatment choices for people living with HIV.
Key takeaways
- Compares two common HIV treatments: Biktarvy (3 drugs) and Dovato (2 drugs).
- Aims to understand how these treatments affect hidden HIV in the body.
- Monitors your overall health, immune system, and virus levels over several years.
- Open to adults aged 18 and over who are living with HIV.
- Involves regular clinic visits and blood tests for up to 5 years.
- You can stop participating at any time.
Who may be eligible?
This study is open to adults who are already living with HIV. To be considered, you must be 18 years old or older. There is no upper age limit for participating.
It's important to note that specific medical requirements may apply beyond just age and having HIV. For example, you would need to be in good general health, and your current HIV treatment would need to meet certain criteria for you to switch to Biktarvy or Dovato as part of the study.
If you are interested, your doctor can help you understand all the detailed requirements and determine if this study might be suitable for you.
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 living with HIV?
- Are you currently taking HIV medication?
- Are you generally in good health?
- Are you willing to switch to either Biktarvy or Dovato as part of the study?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive either Biktarvy (a 3-drug treatment) or Dovato (a 2-drug treatment). Both are standard, effective HIV medications.
Your participation would involve regular visits to the clinic for blood tests and health check-ups. These visits would be frequent at first (for example, at 24 weeks and 48 weeks) and then become less frequent over a longer period, potentially up to five years (240 weeks). During these visits, researchers will collect blood samples to measure your viral levels, assess your immune system, and check other health markers. You will continue to take your assigned study medication daily. The total duration of your participation could be up to 5 years, with follow-up appointments spread out over this time.
Potential risks and benefits
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Common questions
What is the main purpose of this study?
The study compares two different HIV medications, Biktarvy and Dovato, to see how well they control the virus and affect overall health over time.
How long will I be in the study?
Your participation could last up to five years, with regular check-ups and blood tests during that time.
Will I know which drug I'm taking?
Yes, you would know whether you are taking Biktarvy (the 3-drug treatment) or Dovato (the 2-drug treatment) as part of the study.
Are Biktarvy and Dovato safe?
Both Biktarvy and Dovato are approved and widely used HIV treatments. Your doctor will discuss their known side effects and benefits with you.
Can I leave the study if I change my mind?
Yes, you have the right to leave the study at any time, and this will not affect your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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