Study Comparing Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV Treatment in Adults New to Antiretroviral Therapy

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What is this study about?

This clinical trial is focused on studying the treatment of HIV, which stands for Human Immunodeficiency Virus. The study is comparing two different medication regimens for adults who have not previously taken antiretroviral therapy, which is the treatment used to manage HIV. The first treatment being studied is a two-drug combination called Dovato, which contains the active substances lamivudine and dolutegravir sodium. The second treatment is a three-drug combination known as Biktarvy, which includes emtricitabine, tenofovir alafenamide, and bictegravir.

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of these two treatment regimens. Participants will be randomly assigned to receive either the two-drug or the three-drug regimen, and they will take their assigned medication once daily. The study will monitor the participants over a period of time to see how well the virus is controlled, as well as to observe any side effects or other health changes that may occur.

Throughout the study, the main goal is to determine if the two-drug regimen is not less effective than the three-drug regimen in controlling the virus in people who are new to antiretroviral therapy. Participants will have regular check-ups and tests to measure the amount of virus in their blood and to assess their overall health. The study aims to provide valuable information on the best treatment options for managing HIV in adults who are starting therapy for the first time.

1 enrollment

Upon joining the study, confirm eligibility by meeting all criteria, including being at least 18 years old, not having taken any antiretroviral therapy before, and providing written informed consent.

For female participants, a negative pregnancy test is required at the start of the trial.

2 initial assessment

Undergo a baseline assessment to measure initial health status, including HIV-RNA levels and CD4+ cell count.

This assessment helps in tracking changes over the course of the trial.

3 medication administration

Receive one of two oral medication regimens: Dovato (containing dolutegravir and lamivudine) or Biktarvy (containing bictegravir, emtricitabine, and tenofovir alafenamide).

Take the assigned medication once daily as a film-coated tablet.

4 ongoing monitoring

Attend regular follow-up visits to monitor health status and medication effects.

These visits include blood tests to measure HIV-RNA levels and CD4+ cell count at specified intervals, such as Week 48 and Week 96.

5 evaluation of outcomes

The primary goal is to achieve HIV-RNA levels below 50 copies/mL by Week 48.

Secondary outcomes include maintaining these levels through Week 96 and monitoring any disease progression.

6 completion

Upon completing the trial, a final assessment will be conducted to evaluate overall health and treatment efficacy.

Participants may receive information on further treatment options based on the trial results.

Who Can Join the Study?

  • Must be at least 18 years old at the time of giving consent.
  • Can be male or female.
  • If female, must not be pregnant (confirmed by a negative pregnancy test) and must not be breastfeeding.
  • Must have HIV and have not received any treatment for it before (known as being antiretroviral-naïve).
  • Must be able to give written consent to participate in the study.

Who Cannot Join the Study?

  • People who do not have HIV (Human Immunodeficiency Virus) cannot participate.
  • Individuals who have previously received treatment for HIV are not eligible.
  • Participants must be within the specified age range for the study.
  • Pregnant or breastfeeding women are not allowed to join the study.
  • Individuals with certain medical conditions that could interfere with the study results are excluded.
  • Participants must not be part of any other clinical trial at the same time.
  • People who are unable to follow the study procedures or attend scheduled visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Centre Hospitalier Universitaire De Nimes Nimes France
Universitair Ziekenhuis Gent Gent Belgium
CHU Saint Pierre Brussels Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Lodz Poland
ICH Study Center GmbH & Co. KG Hamburg Germany
Institute Of Tropical Medicine Antwerp Belgium
Azienda Ospedaliera di Padova Padua Italy
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Praxis Ebertplatz Cologne Germany
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Karolinska University Hospital Solna Sweden
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital General Universitario De Valencia Valencia Spain
Hospital Son Llatzer Palma Spain
General Hospital Of Athens Korgialenio Benakio H.R.C. Athens Greece
Centre Hospitalier Universitaire De Nice Nice France
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Berlin Germany
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.) Aveiro Portugal
Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wroclaw Poland
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Hospital Universitario De Canarias La Laguna Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Hospital Costa del Sol Marbella Spain
Beaumont Hospital Dublin Ireland
Ahqabkn Ostcgmdrash Perx Gzembivi Xwzdy Bergamo Italy
Hhzoqfjy Hnbqnqzo Hvidovre Denmark
Lhlhy Gwffoyq Hpripvbi Ot Anqncs Athens Greece
Wkenkeyred Srqwikp Odkggvwmgiltdgbvnbpv Ix Tktogecz Bvsaxbav Bydgoszcz Poland
Govapx Ugchzjwjsm Fehloigfs Frankfurt Germany
Kzvsxjaf day Udwtnpwhwdka Myjdsnzy Awu Munich Germany
Furheiljf Padf Lv Iurjeridywiyv Boyessetj Drd Heozmemi Uzyjlxennrtiy Lu Pai Madrid Spain
Hcpuvxci Uqapyyzmzrqkd Hlmkqudw Tyzvh y Pxyxyp Ixflzhsh Cflfcc dqgfxzoxrbgrbvrod (cffa 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
15.01.2024
Denmark Denmark
Not recruiting
15.01.2024
France France
Not recruiting
15.01.2024
Germany Germany
Not recruiting
15.01.2024
Greece Greece
Not recruiting
15.01.2024
Ireland Ireland
Not recruiting
15.01.2024
Italy Italy
Not recruiting
15.01.2024
Poland Poland
Not recruiting
15.01.2024
Portugal Portugal
Not recruiting
15.01.2024
Spain Spain
Not recruiting
15.01.2024
Sweden Sweden
Not recruiting
15.01.2024

Trial locations

Dolutegravir is a medication used to treat HIV. It works by blocking a protein that the virus needs to multiply, helping to lower the amount of virus in the body. This can improve the immune system and reduce the risk of developing HIV-related illnesses.

Lamivudine is another medication used to treat HIV. It helps to decrease the amount of HIV in the body by interfering with the virus’s ability to replicate. This can help improve the immune system and reduce the risk of complications associated with HIV.

Bictegravir is a medication that helps control HIV infection. It works by preventing the virus from multiplying in the body, which helps to lower the viral load and improve the immune system’s function.

Emtricitabine is used to treat HIV by reducing the amount of virus in the body. It helps to prevent the virus from multiplying, which can improve the immune system and decrease the chance of developing HIV-related health issues.

Tenofovir alafenamide is a medication that helps manage HIV infection. It works by blocking the virus from multiplying, which helps to lower the viral load and support the immune system in fighting the infection.

Investigated diseases:

Human immunodeficiency virus (HIV) – HIV is a virus that attacks the body’s immune system, specifically the CD4 cells, which are a type of white blood cell. Over time, HIV can destroy so many of these cells that the body can’t fight off infections and diseases. The virus progresses through several stages, starting with acute infection, where flu-like symptoms may occur. This is followed by a chronic stage, where the virus multiplies at lower levels and may not cause symptoms. Without intervention, HIV can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely damaged. The progression of the disease can vary greatly among individuals.

Trial ID:
2023-504993-40-00
Protocol code:
219816
NCT ID:
NCT05979311
Trial Phase:
Therapeutic confirmatory (Phase III)

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