(CAbotégravir LENacapavir DUal Long Acting). Phase II, Pilot study, open label, multicenter, evaluating dual antiretroviral therapy with long-acting cabotegravir/lenacapavir IMEA 069 - CALENDULA
This study, called CALENDULA, is investigating a new way to treat HIV using two long-acting medicines, cabotegravir and lenacapavir. These medicines are given as injections or tablets. The main aim is to see how many people keep their HIV well-controlled (meaning the virus level stays very low) after 48 weeks. Researchers will also check for any side effects and how the medicines affect general health. It's an important step to find more convenient and effective treatment options for adults living with HIV, potentially reducing the need for daily pills.
At a glance
What is this study about?
This study, called CALENDULA, is an important research project looking into new ways to treat HIV. For a long time, people with HIV have needed to take daily tablets to keep the virus under control. This study is exploring a different approach: using two long-acting medicines together, called cabotegravir (Vocabria) and lenacapavir (Sunlenca).
The main goal is to see how well this combination of medicines works to keep the HIV virus at very low levels in the body over 48 weeks (just under a year). This is known as preventing 'virological failure', which simply means the virus is multiplying more than it should. Researchers will be looking to see if the virus stays undetectable, or below a certain very low level. They will check this regularly through blood tests. This study is in an advanced stage, meaning doctors already have a good idea these medicines are generally safe and work well individually.
Beyond controlling the virus, the study will also track other important things. This includes looking at side effects – how often they happen and if they are serious. They'll also monitor changes in immune cells (CD4 and CD8) which are important for fighting infections, and check general health markers like weight, cholesterol, and other blood tests. This helps build a full picture of how the treatment affects people and whether it offers a good quality of life.
Key takeaways
- This study is testing two long-acting HIV medicines given together.
- The main goal is to see how well these medicines keep HIV under control for 48 weeks.
- It aims to find less frequent ways to treat HIV, potentially replacing daily pills.
- Researchers will also track side effects and overall health improvements.
- Open to adults aged 18 and over, both men and women living with HIV.
Who may be eligible?
To join this study, you would need to be an adult, at least 18 years old. There's no upper age limit, meaning older adults can also take part.
Both men and women can participate in this research. The study needs to include people from all walks of life to get a full understanding of how the medicines work in different individuals.
Key to joining is that you are living with HIV. The research specifically focuses on this condition to test new treatment approaches.
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 able to attend regular clinic appointments for about a year?
- Are you willing to receive study medication, potentially as injections?
- Are you able to provide informed consent (understand and agree to participate)?
What does participation involve?
If you decide to take part in this study, you'd be given a combination of long-acting cabotegravir and lenacapavir. These might be given as injections, or as tablets to start with, followed by injections. The details of how the medicines are given will be fully explained by the study team.
You would have regular visits to the clinic over a period of 48 weeks (about 11 months). During these visits, the study team would: * Give you the study medication. * Take blood samples to check how well the treatment is working (measuring your viral load) and to monitor your general health, including immune cells and other body functions. * Ask you about any side effects or how you are feeling. * Record your weight and other health information.
The study also includes follow-up beyond the 48-week mark to gather more information, but the most intensive part of the study is during this initial period.
Potential risks and benefits
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Common questions
What is HIV viral load?
Viral load is a measurement of how much HIV is in your blood. A low or 'undetectable' viral load means the treatment is working well to keep the virus under control.
What does 'long-acting' mean in this study?
Long-acting means the medicines work in your body for a longer time, so you don't have to take them as often as daily pills. They might be given as injections instead.
What are CD4 and CD8 cells?
CD4 and CD8 cells are types of immune cells, like your body's defence forces. HIV affects CD4 cells, so tracking them helps doctors understand your immune system's health.
What if the treatment doesn't work for me?
The study team will closely monitor your viral load. If the treatment isn't working, they will discuss other options with you to ensure you continue to receive effective HIV care.
Will I know which treatment I'm receiving?
This study is 'open label', which means both you and the study team will know which medicines you are receiving throughout the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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