#1 Clinical Trials Search in Europe

Study on Switching to Emtricitabine, Tenofovir Alafenamide, and Bictegravir for HIV-1 Patients Unable or Unwilling to Continue Injectable Therapy

3 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the immune system. The study involves participants who are currently managing their condition with injectable medications called cabotegravir and rilpivirine. The trial aims to evaluate the safety and effectiveness of switching to an oral medication called Biktarvy, which is a combination of three active substances: emtricitabine, tenofovir alafenamide, and bictegravir. These substances work together to help control the virus in the body.

The purpose of the study is to assess how safe it is for participants to switch from their current injectable treatment to the oral medication Biktarvy. Participants in the study will take Biktarvy tablets daily for a period of 24 weeks. During this time, researchers will monitor the participants’ health and the levels of the virus in their blood. The study will also look at how satisfied participants are with their new treatment compared to their previous one.

Throughout the study, participants will have regular check-ups to ensure their safety and to track any changes in their health. The study will also measure the concentration of the medications in the blood at different points in time. This information will help researchers understand how well the new treatment works and if there are any side effects. The trial is designed to provide valuable insights into the potential benefits of switching to an oral treatment for managing HIV-1 infection.

1 joining the study

Upon joining the study, participants will switch from their current injectable treatment to an oral medication regimen. This involves stopping the use of cabotegravir and rilpivirine injections.

2 medication administration

Participants will begin taking Biktarvy tablets, which contain the active substances bictegravir, emtricitabine, and tenofovir alafenamide. The dosage is one tablet taken orally each day.

The medication is a film-coated tablet designed for easy swallowing.

3 monitoring and assessments

Participants will undergo regular monitoring to assess the safety and effectiveness of the new medication. This includes checking for any side effects or changes in health status.

Blood tests will be conducted at specific intervals: Day 1, Week 4, Week 12, and Week 24 to measure the levels of the medication in the body and to ensure the virus remains suppressed.

4 evaluation of treatment satisfaction

Participants will be asked to complete a questionnaire to evaluate their satisfaction with the new treatment at Week 4. This helps to understand the personal impact of the medication switch.

5 completion of study

The study will continue until Week 24, with the primary focus on safety and maintaining viral suppression. Participants will be monitored for any significant changes in their health or treatment response.

Who Can Join the Study?

  • Participants must be 18 years of age or older and able to understand and give written consent to join the study.
  • The level of bilirubin in the blood should be 1.5 mg/dL or less. Bilirubin is a substance made by the liver.
  • Participants should not have any known or suspected resistance to the medications BIC, FTC, or tenofovir. These are types of HIV medications.
  • Participants must be willing and able to follow all the study requirements.
  • Participants or their healthcare provider must decide to stop using CAB+RPV injections due to side effects, inconvenience, or a desire to switch to daily oral medication.
  • Participants must currently have HIV-1 RNA levels less than 50 copies/mL while on CAB+RPV injections. This means the virus is well-controlled.
  • Participants must have received at least one dose of CAB+RPV injections and not missed any doses.
  • Participants must be able to start the new medication B/F/TAF up to 7 days before their next scheduled CAB+RPV injection.
  • Participants must have had HIV-1 RNA levels less than 50 copies/mL for at least 6 months before the screening visit. A temporary increase in HIV-1 RNA levels, known as a “blip,” is acceptable if it was not confirmed in two consecutive tests.
  • Participants must have adequate kidney function, with an estimated GFR of 30 mL/min or higher. GFR is a measure of how well the kidneys are working.
  • Participants who were assigned female at birth and can have children must agree to use specific methods of birth control if they engage in heterosexual intercourse.
  • The levels of liver enzymes, AST and ALT, should be 5 times the upper limit of normal or less. These enzymes are indicators of liver health.

Who Cannot Join the Study?

  • Individuals who are not infected with HIV-1, which is a type of virus that affects the immune system, cannot participate.
  • Participants who are not currently taking cabotegravir and rilpivirine injections, which are specific medications for HIV treatment, or those who do not wish to switch to oral therapy, are excluded.
  • People who are not within the specified age range for the study cannot join. The study is open to certain age groups only.
  • Individuals who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.

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
Centre Hospitalier Universitaire d’Orléans Orléans France
Avfwgdqcoa Ptmnhzzf Hzbpflvs Dl Mjrfdlhrs Marseille France
Hedchsty Ugudyfzrhqodkt Sztukoefws &ktzhtc Hnuibxr dk Hbckfqmhcnd STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.03.2024

Trial locations

Investigated drugs:

Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) is a combination medication used in this study to evaluate its safety and effectiveness when taken orally. It is intended for participants who are currently virologically suppressed and are either unable or unwilling to continue with their current injectable treatment. This medication is designed to maintain viral suppression in individuals with HIV.

Cabotegravir and Rilpivirine (CAB+RPV) are injectable medications that participants in the study are switching from. These medications are used together to treat HIV and are administered as injections. The study involves participants who wish to transition from these injections to an oral therapy.

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4 cells. Over time, the virus reduces the number of these cells, weakening the body’s ability to fight infections and diseases. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, the infection can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, influenced by factors such as viral load and immune response. Regular monitoring and management are essential to control the infection and maintain health.

Trial ID:
2023-506660-13-00
Protocol code:
GS-US-380-6738
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study of islatravir and ulonivirine for adults with HIV who have not received previous treatment

    Recruiting

    4 1 1
    Investigated drugs:
    France Spain

  • A study testing VH4524184 with emtricitabine and tenofovir alafenamide compared to dolutegravir and lamivudine in adults with HIV-1 who have not received treatment before

    Recruiting

    2 1 1 1
    Investigated drugs:
    Belgium France Germany Italy Poland Portugal +1