Study Comparing Doravirine and Dolutegravir-Based Treatments for People with HIV-1 Who Have Not Yet Started Therapy

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What is this study about?

This clinical trial is focused on studying treatments for HIV-1 infection, a virus that attacks the immune system. The study will compare two different treatment regimens to see if one is not worse than the other. One treatment involves the use of a medication called Delstrigo, which contains the active substances lamivudine, doravirine (also known as MK-1439), and tenofovir disoproxil. The other treatment involves medications that include dolutegravir sodium and a combination of emtricitabine and tenofovir disoproxil, found in a medication called Truvada.

The purpose of the study is to evaluate the effectiveness of these treatments in people who have not received any prior treatment for their HIV-1 infection. Participants will be randomly assigned to receive one of the treatment regimens. The study will last for a period of 24 months, during which participants will take the medication orally, in the form of film-coated tablets, once a day. Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment.

The main goal is to see how well the treatments work in reducing the amount of the virus in the blood to very low levels. The study will also look at other health factors, such as weight changes, blood pressure, and any side effects that may occur. This information will help determine the best treatment options for people living with HIV-1 infection.

1 joining the study

Upon joining the study, the participant will be randomly assigned to one of two treatment groups. This assignment is part of the study’s design to compare the effectiveness of different medication regimens.

2 medication administration

Participants will receive one of the following medication regimens:

Regimen 1: Delstrigo (containing lamivudine, doravirine, and tenofovir disoproxil) taken orally as a film-coated tablet.

Regimen 2: Tivicay (containing dolutegravir sodium) taken orally as a film-coated tablet, in combination with Truvada (containing emtricitabine and tenofovir disoproxil) also taken orally as a film-coated tablet.

The medications are to be taken daily as prescribed by the study protocol.

3 monitoring and assessments

Participants will undergo regular monitoring to assess the effectiveness of the treatment. This includes measuring the level of HIV-1 RNA in the blood to determine if it falls below 50 copies/mL, which is a key indicator of treatment success.

Assessments will occur at various intervals, with significant evaluations at Week 48 and Week 96.

4 evaluation of health parameters

Throughout the study, various health parameters will be evaluated, including weight, blood pressure, and blood sugar levels. These assessments help to monitor any changes in health status that may occur during the trial.

Participants will also be checked for any new health conditions such as obesity, hypertension, or diabetes.

5 completion of the study

The study is expected to conclude by September 2027. At the end of the study, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment regimens.

Who Can Join the Study?

Be at least 18 years old on the day of signing the informed consent.
Be HIV-1 positive, which means having the HIV-1 virus, as determined by national testing strategies.
Have a plasma HIV-1 RNA level of 1000 copies/mL or more within 30 days before the randomization. This is a measure of the amount of HIV in the blood.
Have a need for HIV treatment based on a doctor’s assessment according to local treatment guidelines.
Be naïve to antiretroviral therapy (ART), meaning not having received any treatment for HIV infection, including experimental drugs.
For women or transgender men who can have children: Have a negative urine pregnancy test and agree to use birth control methods. This applies to those who are of childbearing age, not menopausal, or not permanently unable to have children (e.g., due to surgery).
Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial.
For patients in France, be affiliated with a Social Security program, CMU (Universal Health Cover), or AME (State Medical Aid).

Who Cannot Join the Study?

Patients who have previously been treated for HIV-1 infection cannot participate. This means if you have taken any medication for HIV-1 before, you are not eligible.
Patients with a viral load of less than 1,000 copies/mL before treatment are not eligible. Viral load refers to the amount of HIV virus in your blood.
Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Pellegrin Hospital	Bordeaux	France
Csc Nmqbwm	Nantes	France
Hjhdiya Ls Cgwcmdsngn	Montpellier	France
Aixfnepwms Pwkwcqrb Hblfhrko Dk Ppfeb	Paris	France
Uvdjwzvyfk Hhjabtohk Pvxjf Sjzjnivjraf Cfkauwf Fbbv	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Doravirine is a medication used in the trial to treat people living with HIV-1. It is being tested to see if it is as effective as another medication in controlling the virus. Doravirine is combined with other medications to help reduce the amount of HIV in the body.

Dolutegravir is another medication used in the trial for treating HIV-1. It is being compared to doravirine to determine which is more effective in reducing the virus in people who have not been treated before. Dolutegravir is also used with other medications to help manage HIV.

Tenofovir is a medication that is used in combination with other drugs in the trial to help control HIV-1. It works by reducing the amount of virus in the body, which helps improve the immune system.

Lamivudine is part of the combination of medications used in the trial to treat HIV-1. It helps lower the amount of virus in the body and is used alongside other medications to enhance treatment effectiveness.

Emtricitabine is another medication that may be used in combination with dolutegravir and tenofovir in the trial. It works similarly to lamivudine by helping to reduce the amount of HIV in the body and is used to improve the overall treatment outcome.

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4 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 treatment, it typically advances through stages, starting with acute infection, followed by a clinical latency period, and eventually leading to acquired immunodeficiency syndrome (AIDS). During the acute phase, individuals may experience flu-like symptoms, while the latency stage may have few or no symptoms. As the disease progresses to AIDS, the immune system becomes severely compromised, leading to increased vulnerability to opportunistic infections and illnesses.

Trial ID:

2023-508626-10-00

Protocol code:

ANRS0392s ELDORADO

NCT ID:

NCT06203132

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Doravirine and Dolutegravir-Based Treatments for People with HIV-1 Who Have Not Yet Started Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?