Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Raltegravir

    Raltegravir is administered orally, typically in tablet form, and is used to treat HIV infections. It is currently well-established in medical practice and literature, particularly for its use in pregnant women to manage HIV. The main therapeutic indication for raltegravir is to reduce the amount of HIV in the body, helping to improve immune function. At the molecular level, raltegravir works by inhibiting an enzyme called integrase, which is essential for the HIV virus to replicate and integrate into human DNA. It is classified as an antiretroviral medication, specifically an integrase inhibitor.

  • Dolutegravir

    Dolutegravir is taken orally, usually as a tablet, and is used to treat HIV infections. It is widely recognized in the medical community and literature, especially for its effectiveness in pregnant women with HIV. The primary therapeutic use of dolutegravir is to lower the levels of HIV in the body, thereby enhancing the immune system's function. On a molecular level, dolutegravir blocks the integrase enzyme, which the HIV virus needs to multiply and insert its genetic material into human cells. It belongs to the pharmacological class of antiretroviral drugs known as integrase inhibitors.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515487-31-00Protocol code103900Estimated enrolment211 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.