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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)

This study, called PANNA, is looking into how different HIV medicines work in the bodies of women who are pregnant or have recently given birth. Researchers want to understand how these medicines are absorbed, used, and leave the body, both during pregnancy and after the baby is born. They are also checking how much medicine reaches the baby through the umbilical cord or breast milk, and if the baby's body processes the medicine. The aim is to ensure that pregnant women with HIV receive the most effective treatment to keep themselves healthy and prevent HIV from being passed to their babies. This research helps doctors prescribe the best and safest HIV treatments for mothers and their children.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Stichting Radboud universitair medisch centrum
Enrolment target
163
Start
16 Oct 2024

What is this study about?

The PANNA study is focused on understanding how various HIV medicines behave in the bodies of pregnant women. When a woman is pregnant, her body goes through many changes, and these changes can affect how medicines are absorbed, how long they stay in the body, and how they are eventually removed. This is super important for HIV medicines because doctors need to make sure the right amount of medicine is in the body to control the virus effectively, both for the mother's health and to prevent the virus from passing to the baby.

Researchers will be looking at several things. They want to compare how the medicines work during pregnancy versus how they work after the baby is born. This helps them understand the impact of pregnancy on the medicine's effects. They also want to check if the level of medicine in the mother's blood is strong enough to fight the virus and if the baby receives any of the medicine through the umbilical cord or breast milk. Understanding these details helps doctors choose the safest and most effective treatments for pregnant women with HIV.

By gathering this information, the study aims to improve guidelines for treating HIV-positive pregnant women in the future. The ultimate goal is to ensure that mothers stay healthy, and that their babies are born free of HIV. This research is a crucial step in making sure that HIV treatment is as safe and effective as possible for this particular group of patients.

Key takeaways

  • This study focuses on HIV medications in pregnant women.
  • It aims to improve treatment safety and effectiveness for mothers and babies.
  • Participation involves monitoring medication levels in your body.
  • Your health and your baby's health would be closely watched.
  • It's about understanding how common HIV drugs work during pregnancy and after.
  • The findings will help guide future HIV care for pregnant women.

Who may be eligible?

This study is looking for women who are living with HIV. You would need to be at least 18 years old to take part. The study is specifically for women who are either currently pregnant or have recently given birth.

It's important that you are already diagnosed with HIV to be considered for this study, as it's looking at how existing HIV medicines work in this specific situation.

The research focuses on women, as it's about pregnancy and how medicines affect both the mother and the baby. If you fit these general descriptions, you might be eligible to learn more about joining.

Quick self-check
  • Are you a woman?
  • Are you living with HIV?
  • Are you 18 years old or older?
  • Are you currently pregnant or have you recently given birth?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would primarily be helping researchers understand how your HIV medication works in your body during and after pregnancy. This would involve regular blood tests to measure the levels of your medication at different times. You might also have blood taken from your baby's umbilical cord at birth and, if you choose to breastfeed, samples of your breast milk. If it applies, they might also check how quickly the medicine leaves your baby’s system.

The study will follow your progress and your baby's health at key points, looking at how well your HIV is controlled and your baby's infection status. They will also keep track of any side effects you or your baby might experience. The total duration of your involvement could extend from during your pregnancy until sometime after you give birth, especially if you breastfeed, to collect all the necessary information.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as very close monitoring of your health and your baby's health during and after pregnancy. The information gathered will also help improve HIV treatment for future pregnant women. However, there are potential risks, primarily related to the blood tests, which might cause minor discomfort, bruising, or rarely, infection. The study involves medicines you would already be taking for your HIV, but the extra monitoring can identify any unexpected effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

  • Spain
  • Ireland
  • Netherlands
  • Belgium
  • Germany

Common questions

What is this study trying to find out?

It's trying to understand how HIV medicines work in the bodies of pregnant women and how they might affect their babies.

Who can join this study?

Women living with HIV who are 18 or older and are currently pregnant or have recently given birth are eligible.

Will I have to change my HIV medication?

The study looks at medicines you would already be taking, so it's unlikely you'd change medication just for the study, but your doctor will advise you.

What does 'pharmacokinetics' mean?

It's a scientific word for how the body handles a medicine – how it's absorbed, distributed, processed, and eventually leaves the body.

Will my baby be affected by taking part?

The study aims to ensure the safest treatment for mothers and babies. Any samples from your baby would be taken with your permission and your baby's safety as a priority.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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