Study on the Effectiveness and Safety of Lamivudine, Dolutegravir Sodium, Cabotegravir, and Rilpivirine for Adults with HIV-1 Who Have Not Taken Antiretroviral Therapy

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What is this study about?

This clinical trial is focused on studying the treatment of HIV-1 infection in adults who have not previously taken any antiretroviral therapy. The study will use two different treatment approaches. Initially, participants will take a daily oral medication called Dovato, which contains the active substances lamivudine and dolutegravir sodium. After achieving control of the virus, participants will have the option to switch to a long-acting injectable treatment given every two months. This injectable treatment consists of two medications: Vocabria, which contains cabotegravir, and REKAMBYS, which contains rilpivirine.

The purpose of the study is to evaluate how well these treatments work in suppressing the HIV virus in the blood and maintaining this suppression over time. Participants will start with the oral medication to achieve initial control of the virus. Once the virus is under control, they can choose to continue with the oral medication or switch to the injectable treatment. The study will monitor the effectiveness and safety of both treatment options, as well as participants’ preferences and experiences with the treatments.

Throughout the study, participants will receive regular check-ups to assess their health and the effectiveness of the treatment. The study aims to provide valuable information on the best ways to manage HIV-1 infection in adults who are new to antiretroviral therapy. Participants will have the opportunity to choose the treatment option that best suits their lifestyle and preferences, while the study gathers important data on the outcomes of these treatments.

1 initial treatment phase

Begin taking Dovato, which contains lamivudine and dolutegravir sodium, as a film-coated tablet.

Take one tablet orally once a day.

This phase aims to suppress the HIV virus in the blood.

2 monitoring and assessment

Regular monitoring of HIV viral load to ensure it is less than 50 copies per milliliter.

Assessments will occur periodically to evaluate the effectiveness of the treatment.

3 optional switch to injectable regimen

After achieving virologic suppression, there is an option to switch to a long-acting injectable regimen.

This involves receiving Vocabria (cabotegravir) and REKAMBYS (rilpivirine) as intramuscular injections.

Injections are administered every two months.

4 maintenance phase

Continue with the chosen regimen to maintain virologic suppression.

Regular follow-ups and assessments will continue to monitor health and treatment effectiveness.

5 end of study

The study is expected to conclude by August 2026.

Final assessments will be conducted to evaluate long-term outcomes and treatment satisfaction.

Who Can Join the Study?

  • Must be at least 18 years old. In some places, you might need to be older, depending on local rules.
  • Can be male or female. If female, you must not be pregnant, which will be checked with a blood test and a urine test, and you must not be breastfeeding.
  • Must have a certain level of the HIV virus in your blood, specifically at least 1,000 copies per milliliter, as measured during the screening process.
  • Must not have taken any medicine for HIV before joining the study. This means you are antiretroviral-naïve, which means you haven’t had any treatment for HIV since being diagnosed.
  • Must be able to understand and sign a form that explains the study and agree to follow the study’s rules. This is called giving informed consent.
  • If you are joining the study in France, you must be part of a social security system or have benefits from it.

Who Cannot Join the Study?

  • Individuals who have previously received treatment for their HIV-1 infection cannot participate. This means if you have taken any medication to treat HIV before, you are not eligible.
  • Participants who are not adults are excluded. Only adults can join the study.
  • People who are not able to follow the study procedures or attend the required visits are not eligible.
  • Individuals with other significant health issues that might interfere with the study are excluded. This means if you have other serious medical conditions, you may not be able to participate.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Participants who are part of another clinical trial at the same time are not eligible.
  • Individuals with a history of allergic reactions to the study medications are excluded. This means if you have had allergies to similar drugs, you cannot participate.

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
Hospital General Universitario Gregorio Maranon Madrid Spain
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire d’Orléans Orléans France
Ospedale San Raffaele S.r.l. Milan Italy
Assistance Publique Hopitaux De Paris Paris France
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy
ASST Fatebenefratelli Sacco Milan Italy
Hospital General Universitario Morales Meseguer Murcia Spain
Hospital Universitario Infanta Leonor Madrid Spain
Hospital Universitario Torrecardenas Almeria Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
MVZ Munchen Am Goetheplatz Munich Germany
Hospital Universitario Virgen De La Victoria Malaga Spain
Argjoenahj Pottbckx Hcgcoxna De Pirqq Paris France
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Uutitwqwiuwlnqntsqrqq Dwvyoxbxwcs Acr Duesseldorf Germany
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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
26.12.2023
Germany Germany
Not recruiting
26.12.2023
Italy Italy
Not recruiting
26.12.2023
Spain Spain
Not recruiting
26.12.2023

Trial locations

Dolutegravir/Lamivudine is a combination of two medications used as a first-line treatment for adults who are new to antiretroviral therapy. This combination helps to reduce the amount of HIV in the blood, which is known as viral suppression. It is taken orally once a day.

Cabotegravir is a long-acting medication used in combination with another drug to maintain viral suppression in people with HIV. It is given as an injection every two months after the initial treatment phase with oral medications.

Rilpivirine is another long-acting medication that is used together with cabotegravir to help keep the HIV virus suppressed in the body. Like cabotegravir, it is administered as an injection every two months.

HIV-1 Infection – HIV-1 infection is a chronic viral condition caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4+ T cells. As the virus replicates, it gradually weakens the immune system, making the body more susceptible to infections and certain cancers. The progression of the disease can vary, but without intervention, it can lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. During the early stages, individuals may experience flu-like symptoms, but as the infection progresses, symptoms may become more severe and persistent. The virus is primarily transmitted through unprotected sexual contact, sharing needles, or from mother to child during childbirth or breastfeeding. Regular monitoring of viral load and CD4+ cell count is crucial in managing the disease and preventing progression.

Trial ID:
2023-503893-19-00
Protocol code:
219700
NCT ID:
NCT05917509
Trial Phase:
Therapeutic confirmatory (Phase III)

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