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Study on the Effects of Abacavir Sulfate and Etravirine in Pregnant Women with HIV

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What is this study about?

This clinical trial focuses on understanding how certain medications work in pregnant women who are infected with HIV, a virus that attacks the body’s immune system. The study involves several medications, including Ziagen (abacavir sulfate), Intelence (etravirine), Eviplera (emtricitabine, tenofovir disoproxil, rilpivirine), Edurant (rilpivirine), Telzir (fosamprenavir calcium), Trizivir (zidovudine, abacavir sulfate, lamivudine), Delstrigo (lamivudine, doravirine, tenofovir disoproxil), Norvir (ritonavir), Ritonavir Accord (ritonavir), Descovy (emtricitabine, tenofovir alafenamide), Reyataz (atazanavir), Rekambys (rilpivirine), Tivicay (dolutegravir sodium), Viread (tenofovir disoproxil), Emtriva (emtricitabine), Truvada (emtricitabine, tenofovir disoproxil), Biktarvy (emtricitabine, tenofovir alafenamide, bictegravir), Odefsey (emtricitabine, tenofovir alafenamide, rilpivirine), Stocrin (efavirenz), Vocabria (cabotegravir), Aptivus (tipranavir), Pifeltro (doravirine), Celsentri (maraviroc), Kivexa (abacavir sulfate, lamivudine), Isentress (raltegravir), and Fuzeon (enfuvirtide). Some of these medications are known by their code names, such as TMC278 for rilpivirine, MK-1439 for doravirine, GS-9883 for bictegravir, and GSK1265744 for cabotegravir.

The purpose of the study is to gather information on how these medications are processed in the body during pregnancy, particularly in the third trimester, and after childbirth. The study also looks at how these medications affect the baby if the mother is taking them during pregnancy. For some medications, like raltegravir and dolutegravir, the study also examines their effects during the second trimester. The study involves taking these medications orally or through injections, depending on the specific drug being tested.

Participants in the study will take the medications for a period of up to 14 days, with some medications being taken for a longer period. The study will monitor how the medications are absorbed, distributed, and eliminated from the body. This information will help in understanding the safety and effectiveness of these medications for pregnant women and their babies. The study will also look at the health of the mother and the baby during and after pregnancy, including any side effects that may occur.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This form confirms your willingness to participate and your understanding of the study’s procedures and objectives.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your HIV status through a positive HIV antibody test and an antigen test. Your age will be confirmed to ensure you are at least 18 years old.

Your current treatment regimen will be reviewed to ensure it includes at least one of the antiretroviral agents being studied. You must have been on this regimen for at least two weeks prior to the first pharmacokinetic evaluation.

3 treatment during pregnancy

During the third trimester of your pregnancy, the study will focus on understanding how your body processes the antiretroviral medications. This involves measuring the levels of the medication in your blood at different times.

If you are taking raltegravir or dolutegravir, this evaluation may also occur during the second trimester.

4 postpartum assessment

After giving birth, the study will continue to monitor how your body processes the antiretroviral medications. This is to compare the data collected during pregnancy with the data collected after pregnancy.

If you are breastfeeding, the study will also measure the levels of medication in your breast milk and how it affects your child.

5 infant evaluation

In some cases, the study will evaluate the levels of medication in your infant’s blood if they were exposed to the medication before birth. This is to understand how long the medication stays in their system.

The study will also assess the infant’s health and infection status at birth.

6 completion of study

Upon completion of the study, all collected data will be analyzed to understand the effects of the antiretroviral medications during and after pregnancy.

The study aims to ensure that the medication levels remain effective and safe for both you and your child.

Who Can Join the Study?

  • The person must be HIV-infected, which means they have tested positive for HIV antibodies and this has been confirmed by another test.
  • The person must be at least 18 years old at the time of screening.
  • The person must be able and willing to sign a document called the Informed Consent Form before any screening tests are done. This form explains the study and confirms their agreement to participate.
  • The person must be receiving a treatment called cART (combination antiretroviral therapy) that includes at least one specific medication listed in the study details. They must have been taking this medication for at least 2 weeks before the first study evaluation.
  • The person must be pregnant.
  • The person must be able to follow any food intake recommendations if these are part of the study requirements.

Who Cannot Join the Study?

  • Patients who are not HIV-infected cannot participate.
  • Only pregnant women can participate, specifically those in their 2nd or 3rd trimester.
  • Men cannot participate in this study.
  • Participants must be part of a vulnerable population, which means they may need special protection or consideration.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Mater Misericordiae University Hospital Dublin Ireland
CHU Saint Pierre Brussels Belgium
Hospital Universitario Virgen De Las Nieves Granada Spain
St James’s Hospital Dublin Ireland
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Uwaojsxbgjkw Mfleixn Cpwkwml Gwxzexxsc Groningen The Netherlands
Uxhyrufxvc Hlksdfii Chxcwxl Abm Cologne Germany
Awercmhzg Udf Amsterdam The Netherlands
Exrmqbj Uvgvwdbmipdw Muvqsio Cgqvjpn Rcpgdzjyw (yidpthm Mfu Rotterdam The Netherlands
Srx Erhncdeuq Hgwyssdc Tedetym Tilburg The Netherlands
Gjxbze Ubyoojurhr Fbpolipos Frankfurt Germany
Kiogvdjm dkw Urrfgxumlmmc Mmdjpong Awy Munich Germany
Hewxsymi Urkyfrpjgkfor Hvpmoklu Tamol y Pmuatg Iqgmmhiy Cflwli dnyawrpeppjdtxrlo (oueq Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
22.11.2009
Germany Germany
Not recruiting
22.11.2009
Ireland Ireland
Not recruiting
22.11.2009
Spain Spain
Not recruiting
22.11.2009
The Netherlands The Netherlands
Not recruiting
22.11.2009

Trial locations

Investigated drugs:

Raltegravir is a medication used to treat HIV infection. It works by blocking an enzyme called integrase, which the virus needs to multiply in the body. In this study, researchers are looking at how the body processes raltegravir during pregnancy, especially in the second and third trimesters, and after childbirth.

Dolutegravir is another medication used to manage HIV infection. Like raltegravir, it also targets the integrase enzyme, preventing the virus from replicating. The study aims to understand how dolutegravir is absorbed and processed in the body during pregnancy and after delivery.

Human Immunodeficiency Virus (HIV) Infection – HIV infection is caused by the human immunodeficiency virus, which attacks the body’s immune system, specifically the CD4 cells (T cells). Over time, HIV can destroy so many of these cells that the body can’t fight off infections and disease. The virus is transmitted through contact with certain body fluids from a person who has HIV. As the infection progresses, it can lead to acquired immunodeficiency syndrome (AIDS), the most severe phase of HIV infection. During this phase, the immune system is badly damaged, and the body becomes vulnerable to opportunistic infections and certain cancers. The progression of the disease can vary significantly among individuals, with some experiencing rapid progression and others remaining asymptomatic for years.

Trial ID:
2024-515487-31-00
Protocol code:
103900
NCT ID:
NCT00825929
Trial Phase:
Therapeutic confirmatory (Phase III)

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