Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
This research is investigating how different HIV medications behave in the bodies of pregnant women. We know that pregnancy can alter how the body processes medicines, which means the usual doses might not be as effective for expectant mothers living with HIV. The main goal is to check if the current recommended doses of these important drugs provide enough medicine to work properly during pregnancy, particularly in the third trimester when these changes are most noticeable. Researchers will be looking at several widely-used HIV treatments to understand their effects better and ensure the best care for pregnant women and their babies. This study is crucial for optimising HIV treatment during pregnancy in the UK.
At a glance
What is this study about?
When someone is pregnant, their body goes through many changes. These changes can affect how medicines are absorbed, used, and removed from the body. For women living with HIV, it's very important that their anti-HIV medicines work as they should, both for their own health and to prevent passing HIV to their baby. However, for many HIV medicines, we don't know exactly how pregnancy affects them.
This study aims to understand precisely how several common anti-HIV drugs behave in the bodies of pregnant women. The researchers will look at how much medication is in the blood at different times, especially during the third trimester of pregnancy, as this is when the body's changes are most significant. This helps ensure that the current doses of these medicines are still effective for pregnant women.
By gathering this information, doctors can be confident that they are prescribing the correct and most effective doses of HIV medication for pregnant women in the UK. This is vital for maintaining the health of the mother and significantly reducing the risk of HIV transmission to the baby.
Key takeaways
- Study looks at how HIV medicines work in pregnant women.
- Aims to ensure correct dosing for mother and baby's health.
- Involves blood tests during the third trimester.
- Helps minimise risk of HIV transmission to babies.
- Participation contributes to better future care for pregnant women with HIV.
Who may be eligible?
This study is looking for women aged 18 or over who are living with HIV and are currently pregnant. You also need to be taking an anti-HIV medicine that is on the study's list of drugs being investigated, and have been taking it for at least two weeks before your first study visit.
You should also be able to understand what's involved in the study and be willing to sign a consent form. If you have any medical conditions that might affect how your body handles medication, or severe anaemia (low red blood cell count), you might not be able to participate. Also, if you're currently taking oral cabotegravir/rilpivirine, you won't be eligible for this particular study.
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 living with HIV?
- Are you currently pregnant?
- Are you 18 years old or older?
- Are you taking one of the listed anti-HIV medicines?
- Do you feel you understand what the study involves and are willing to consent?
- Do you not have severe anaemia or other conditions affecting medication absorption?
What does participation involve?
If you take part, you'll need to have a 'pharmacokinetic curve' recorded during your third trimester. This means that after you've been taking your usual HIV medication for some time (at least two weeks before this specific visit), you'll have several blood samples taken over a day to measure the levels of your medication. This helps researchers understand how your body is processing the drug. You'll also need to follow any specific instructions about food intake around the time of these blood tests. The total duration of your participation will depend on when you enter the study and when your third-trimester visit takes place, but the main intense 'data collection' part is that single day of blood samples.
Potential risks and benefits
Locations (21)
- Saint-Pierre University Hospital; Department of Infectious DiseasesVerified postcodeBrussels, Belgium· Recruiting
- CHARITÉ BerlinVerified postcodeBerlin, Germany· Recruiting
- University of BonnVerified postcodeBonn, Germany· Recruiting
- University of CologneVerified postcodeCologne, Germany· Recruiting
- Johann Wolfgang Goethe-UniversitätVerified postcodeFrankfurt am Main, Germany· Recruiting
- University MünchenVerified postcodeMünchen, Germany· Recruiting
- Mater Hospital and UCDVerified postcodeDublin, Ireland· Recruiting
- St James's Hospital DublinVerified postcodeDublin, Ireland· Recruiting
- IRCSSVerified postcodeRome, Italy· Completed
- AMCVerified postcodeAmsterdam, Netherlands· Completed
- Radboud University Nijmegen Medical CentreVerified postcodeNijmegen, Netherlands· Recruiting
- Erasmus Medical Center RotterdamVerified postcodeRotterdam, Netherlands· Recruiting
Common questions
Why is this research important?
It's important because pregnancy changes how the body handles medicines, and we need to make sure HIV drugs are still working effectively for both mother and baby.
Will I have to stop my current HIV medicine?
No, you will continue your current anti-HIV medicine. The study observes how it works in your body.
What does a 'pharmacokinetic curve' involve?
It means having several blood tests over one day to measure the levels of your medicine in your blood, to see how your body processes it.
Is there any cost to me to participate?
The study does not mention any costs for participants. All study-related procedures will be covered by the research.
What happens if I change my mind during the study?
You are free to leave the study at any time without giving a reason, and your medical care will not be affected.
How to find out more
David M Burger, PharmD PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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