Study on Switching from Boosted Protease Inhibitors to Fostemsavir for People with HIV-1 with Limited Treatment Options

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What is this study about?

This clinical trial is focused on studying the treatment of HIV-1, a virus that attacks the immune system. The study will explore the effects of switching from a type of medication known as a boosted protease inhibitor to a new medication called fostemsavir trometamol, which is available in the form of Rukobia 600 mg prolonged-release tablets. The purpose of the study is to evaluate how effective and safe this switch is for people living with HIV who have limited treatment options.

Participants in the study will take the new medication orally, which means it is taken by mouth. The study will last for 48 weeks, during which time the researchers will monitor the participants’ health and the level of the virus in their blood. The main goal is to see how many participants have a viral load, which is the amount of virus in the blood, of 50 copies/mL or more at the end of the study period. The study will also look at other health indicators, such as the number of certain immune cells and any side effects experienced by the participants.

Throughout the study, participants will be asked to report any changes in their quality of life and overall health. This information will help researchers understand the benefits and potential challenges of switching to fostemsavir trometamol. The study will also assess the possibility of interactions between the new medication and other drugs the participants may be taking. This trial aims to provide valuable insights into the treatment of HIV-1 for those who have limited options available to them.

1 joining the study

Upon joining the study, the patient will be required to sign an informed consent form. This indicates the patient’s willingness to participate in the trial and understanding of the study’s procedures and objectives.

2 initial assessment

An initial assessment will be conducted to ensure the patient meets the inclusion criteria. This includes confirming the patient is an adult with HIV-1, has been on a stable and suppressive combination antiretroviral therapy (cART) with a viral load of 50 copies/mL or less for one year, and has no significant laboratory abnormalities or medical conditions that would prevent participation.

3 medication switch

The patient will switch from a boosted protease inhibitor to fostemsavir trometamol, administered as Rukobia 600 mg prolonged-release tablets. The medication is taken orally.

4 ongoing monitoring

The patient’s HIV viral load will be monitored at regular intervals to assess the effectiveness of the medication switch. The primary goal is to evaluate the proportion of patients with a viral load of 50 copies/mL or more at week 48.

Secondary assessments will include viral load measurements at weeks 24 and 48, CD4 count, CD4:CD8 ratio, and lymphocyte subsets. The study will also evaluate potential drug interactions and monitor for any adverse events or treatment discontinuations due to tolerability issues.

5 patient feedback

Patient-reported outcomes will be collected to assess changes in quality of life and health perception following the medication switch. This will involve completing specific questionnaires, such as the wellness thermometer, PHQ9, and GAD-7.

6 final assessment

At the end of the study, a final assessment will be conducted to evaluate the overall safety and tolerability of fostemsavir in the patient population. This includes monitoring changes in lipids, glucose, insulin resistance, weight, and waist circumference.

Who Can Join the Study?

The patient must be an adult with HIV-1 infection and be over 18 years old. If the patient is a woman, she must not be able to have children or must agree to use very effective birth control methods.
The patient should be on a stable and effective treatment for HIV, known as cART (combination antiretroviral therapy), with a viral load (amount of HIV in the blood) of 50 copies/mL or less for at least one year. A temporary increase in viral load (between 50-200 copies/mL) is allowed if it goes back below 50 copies/mL for six months before joining the study, and there are no major issues with taking the medication as prescribed.
The patient should be on a specific type of HIV medication called bPI (boosted protease inhibitor) and should not have other options to switch to another approved treatment, except for specific medications like ibalizumab or lenacapavir, if they are available. This is due to problems with previous treatments or resistance to them.
The patient should not have any significant problems in their lab test results, medical or mental health conditions, or issues with alcohol or drug use that would prevent them from participating in the study, as determined by the study doctors.
The patient must be willing to sign a document called an informed consent, which shows they agree to participate in the study and understand what it involves.

Who Cannot Join the Study?

Patients who are not diagnosed with HIV-1 cannot participate. HIV-1 is a type of virus that affects the immune system.
Patients who are under 18 years old or over 65 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of drug or alcohol abuse that could interfere with the study cannot participate.
Patients who have other serious health conditions that could affect the study results cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Sanitaria Locale Citta Di Torino	Turin	Italy
Hjvzkfya Ucxloqcyifokt Dg Lh Ptnlglyg	Madrid	Spain
Febevmnfl Pakg La Ileliiezmzmpr Bduosqrnq Dwb Hxyubjmj Uogoxmlhpcken Lk Poq	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.01.2024
Spain	Not recruiting	01.01.2024

Trial locations

Investigated drugs:

Fostemsavir Trometamol

Fostemsavir is a medication being studied for its effectiveness and safety in people living with HIV who have limited treatment options. It works by preventing the virus from entering and infecting healthy cells, which may help control the viral load in the body. This trial is exploring whether switching to fostemsavir from a different type of HIV medication can maintain or improve the patient’s health.

Investigated diseases:

HIV infection

HIV-1 – Human Immunodeficiency Virus type 1 (HIV-1) is a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for immune defense. Over time, HIV-1 can lead to a significant decrease in CD4 cells, weakening the immune system and making the body more susceptible to infections and certain cancers. The virus is primarily transmitted through unprotected sexual contact, sharing needles, or from mother to child during childbirth or breastfeeding. As the infection progresses, individuals may experience flu-like symptoms initially, followed by a long asymptomatic period. Without intervention, HIV-1 can progress to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely compromised. Monitoring viral load and CD4 count is essential in understanding the progression of the disease.

Trial ID:

2023-504192-25-00

Protocol code:

NEAT808

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Switching from Boosted Protease Inhibitors to Fostemsavir for People with HIV-1 with Limited Treatment Options

What is this study about?

Who Can Join the Study?

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