Study on Switching HIV Treatment to Dolutegravir/Lamivudine in Patients Aged 50+ with Virologic Suppression

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What is this study about?

This clinical trial is focused on studying the treatment of Human Immunodeficiency Virus (HIV) in individuals who are at least 50 years old and have their virus levels under control. The study involves switching from one medication to another. Participants will switch from taking a single tablet regimen called Biktarvy, which contains the active substances emtricitabine, tenofovir alafenamide, and bictegravir, to another single tablet regimen called Dovato, which contains lamivudine and dolutegravir sodium. The purpose of the study is to evaluate how well the new regimen maintains control of the virus.

The study will last for a total of 96 weeks, with participants taking the new medication once daily. During this time, the safety and tolerability of the new treatment will be monitored. Participants will have regular check-ups to ensure that the virus remains suppressed and to observe any changes in their health. The study will also look at the occurrence of any side effects or adverse reactions to the new medication.

Participants will be closely monitored for any signs of the virus becoming resistant to the new treatment. The study aims to provide valuable information on the effectiveness of switching medications in older adults living with HIV, ensuring that their treatment remains effective and safe over time.

1 joining the study

Upon joining the study, participants will begin by taking a single tablet regimen of Biktarvy, which contains emtricitabine, tenofovir alafenamide, and bictegravir. This medication is taken orally once daily.

Participants must have been on this regimen for at least 6 months prior to the start of the study.

2 switching medication

After the initial phase, participants will switch to a new medication called Dovato, which contains lamivudine and dolutegravir sodium. This is also a single tablet taken orally once daily.

The switch is designed to evaluate the maintenance of viral suppression with the new medication.

3 monitoring and evaluation

Participants will be monitored at various intervals to assess the effectiveness and safety of the new medication. Key time points include 24, 48, and 96 weeks after the switch.

The primary goal is to ensure that the viral load remains below 50 copies/mL at Week 48. Secondary evaluations will include viral load assessments at Weeks 24 and 96, as well as changes in immune cell counts.

4 completion of the study

The study is expected to conclude by January 31, 2026. Participants will have completed all required assessments and monitoring by this time.

Final evaluations will include a review of any adverse reactions and overall health outcomes related to the medication switch.

Who Can Join the Study?

  • Must be at least 50 years old at the time of giving consent.
  • Must sign a written consent form before any study-related activities begin.
  • If participating in France, must be part of a social security system.
  • Can be male or female. If female, must not be pregnant or breastfeeding, confirmed by specific tests.
  • Must be living with HIV-1 and have a documented low level of the virus in the blood (less than 50 copies per milliliter) within 3 months before the study starts.
  • Must have been on continuous antiretroviral therapy (ART) for at least 1 year, with short breaks allowed for safety reasons.
  • Must have been on a specific combination of medications (BIC/FTC/TAF) for at least 6 months before the study starts.
  • Must have a low level of the virus in the blood (less than 50 copies per milliliter) at the start of the study.
  • Must not have changed treatment due to a confirmed increase in the virus level (200 copies per milliliter or more).
  • If the full treatment history is unknown for more than 5 years, eligibility can be discussed with a medical expert.
  • Must be able to provide written consent.

Who Cannot Join the Study?

  • Individuals who do not have HIV (Human Immunodeficiency Virus) cannot participate. This is a virus that attacks the body’s immune system.
  • Participants must be able to maintain virologic suppression. This means the virus is controlled and not actively multiplying in the body.
  • Participants must be switching from a specific medication combination called BIC/FTC/TAF to another called DTG/3TC. These are different types of HIV medications.
  • Participants must be within certain age ranges, which are not specified here.
  • Both male and female participants are eligible, but certain conditions may apply.
  • Participants from vulnerable populations may be included, but specific criteria are not detailed here.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Medizinische Universitaet Innsbruck Innsbruck Austria
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Centre Hospitalier Universitaire De Nice Nice France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire d’Orléans Orléans France
Ludwig Maximilian University Of Munich Munich Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Azienda Sanitaria Locale Citta Di Torino Turin Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitair Ziekenhuis Gent Gent Belgium
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Pxie Tmhsb Hqrjqefe Uqzpslgfqoyj Sabadell Spain
Tbnlwurrlqeuxy Wtcb 1xtz uqu Igjctiulrjbkhzmzw Vienna Austria
Cdslifdvh Ujccrmnjvlzasp Sacmwname Woluwe-Saint-Lambert Belgium
Aiwizaapr Ufc Amsterdam The Netherlands
Cilepn Humefxnrwl Uxivxzpsmegqk Da Pxgog Ecnbrn Porto Portugal
Urwqcrbcms Dyhfc Sjbzf Dc Rhyl La Svlritot Rome Italy

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.11.2023
Belgium Belgium
Not recruiting
13.11.2023
France France
Not recruiting
13.11.2023
Germany Germany
Not recruiting
13.11.2023
Italy Italy
Not recruiting
13.11.2023
Portugal Portugal
Not recruiting
13.11.2023
Spain Spain
Not recruiting
13.11.2023
The Netherlands The Netherlands
Not recruiting
13.11.2023

Trial locations

DTG/3TC is a single tablet regimen used in this study. It combines two medications, dolutegravir and lamivudine, into one pill. This combination is used to maintain control of HIV in people who have already achieved viral suppression, meaning the virus is at very low levels in their body. The study is testing how well this combination works when patients switch from another HIV treatment.

BIC/FTC/TAF is another single tablet regimen that combines three medications: bictegravir, emtricitabine, and tenofovir alafenamide. This combination is used to control HIV by keeping the virus at low levels in the body. In this study, patients who are already taking this combination and have their virus under control are switching to the DTG/3TC regimen to see if they can maintain their viral suppression.

Human Immunodeficiency Virus (HIV) – HIV is a virus that attacks the body’s immune system, specifically the CD4 cells (T cells), which are crucial for fighting infections. 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 of an infected person, most commonly during unprotected sex or through sharing needles. As the virus progresses, it can lead to acquired immunodeficiency syndrome (AIDS), the most severe phase of HIV infection. During this stage, the immune system is badly damaged, and the body becomes vulnerable to opportunistic infections and certain cancers. Without treatment, HIV can gradually weaken the immune system, but with proper management, individuals can maintain a healthy life.

Trial ID:
2022-503137-66-00
Protocol code:
219516
NCT ID:
NCT05911360
Trial Phase:
Therapeutic confirmatory (Phase III)

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