Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study on PhArmacokiNetics of first liNe Antiretrovirals in healthy Breastfeeding volunteers or women living with HIV and already on antiretrovirals

This study is called 'PhArmacokiNetics of first liNe Antiretrovirals in healthy Breastfeeding volunteers or women living with HIV and already on antiretrovirals'. It's investigating how anti-HIV medicines, often called antiretrovirals, move through and are used by the body. Specifically, it focuses on these medicines in healthy women who are breastfeeding and women with HIV who are already on treatment. The main goal is to gather important information about how these medicines behave in breastfeeding mums, which can help ensure safe and effective treatment options for both mother and baby. It's an early-stage study, meaning it's focused on understanding how the medicine works in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Stichting Radboud University Medical Center

Enrolment target

Start

12 Sep 2024

healthy breastfeeding women

What is this study about?

This study wants to learn more about how certain medicines for HIV work in the bodies of women who are breastfeeding. These medicines are called 'antiretrovirals'. They are very important for managing HIV, but we need to understand exactly how they behave when a woman is breastfeeding, especially how much might pass into breast milk.

Researchers will be looking at how these medicines are absorbed, distributed around the body, processed, and eventually leave the body. This is called 'pharmacokinetics'. They want to see if there are any differences in breastfeeding women compared to others, and specifically, if there are any changes when a woman is taking these medicines while nursing her baby. This information is crucial for making sure that medicines are used safely and effectively for both mothers and their babies.

By carefully studying this, researchers hope to get a better understanding of how these anti-HIV medicines work in breastfeeding mums. This knowledge can help doctors make the best decisions about treatment plans for women with HIV who want to breastfeed, ensuring the health and well-being of both mother and child.

Key takeaways

This study focuses on how anti-HIV medicines work in breastfeeding women.
It aims to understand how these medicines move through and are used by the body.
The study includes healthy breastfeeding women and women with HIV already on treatment.
It's an early-stage study, gathering important information about medicine behaviour.
The goal is to improve safe and effective treatment options for mothers and babies.

Who may be eligible?

This study is looking for women aged 18 or older. You must be female to take part.

You might be able to join if you are a healthy woman who is breastfeeding. Alternatively, if you are a woman living with HIV and are already taking anti-HIV medicines, you might also be suitable. The study is very specific about who can join to make sure it's safe and that the results are clear.

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 female?
Are you 18 years old or older?
Are you currently breastfeeding and healthy?
Or, are you a woman living with HIV and already taking anti-HIV medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to attend several appointments. During these visits, the study team would likely take some blood or urine samples to check how the medicine is moving through your body. They would also monitor your health closely. You wouldn't be given new medicine you haven't taken before if you're already on HIV treatment; the focus is on how it's working for you now. The full duration of your involvement, including all visits and follow-up, would be fully explained to you before you agree to participate.

Potential risks and benefits

Taking part in any study has potential pros and cons. A possible benefit is helping researchers understand more about how HIV medicines work in breastfeeding women, which could improve care for others in the future. As for risks, there might be some discomfort from blood tests, and certain medicines can have side effects, though the study aims to understand approved treatments. The study team will explain all known risks. Remember, you can decide to stop being part of 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
Netherlands

Common questions

What kind of medicines are they studying?

They are studying anti-HIV medicines, also known as antiretrovirals, which are used to treat people with HIV.

Why is this study important for breastfeeding women?

It's important to understand how these medicines behave in breastfeeding women to ensure they are safe and effective for both the mother and the baby.

Will I have to stop breastfeeding to take part?

The study is specifically for breastfeeding women, so you would not be asked to stop. They want to see how the medicines work while you are breastfeeding.

Is this a very new medicine?

No, this study is looking at how existing, first-line anti-HIV medicines work in the body, not necessarily a brand new experimental drug.

Will I get paid to take part?

The study information doesn't say if participants will be paid. You should ask the study team about this.