Study on HIV-1 Treatment for Patients New to Therapy: Comparing Doravirine/Islatravir with a Drug Combination

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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 two different treatment groups. One group will receive a combination of medications called doravirine and islatravir, which are taken as a single pill once a day. The other group will receive a different combination of medications known as bictegravir, emtricitabine, and tenofovir alafenamide, also taken as a single pill once a day. These medications are designed to help control the virus in people who have not previously received antiretroviral therapy, which is the standard treatment for HIV.

The purpose of this study is to compare the effectiveness, safety, and tolerability of the two treatment options over a period of time. Participants will be randomly assigned to one of the two groups and will not know which treatment they are receiving, as the study is double-blind. This means that neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. The study will last for a total of 96 weeks, with regular check-ups and assessments to monitor the participants’ health and the virus’s response to the treatment.

Throughout the study, the main focus will be on how well the treatments reduce the amount of HIV-1 RNA in the blood, which is a measure of the virus’s activity. Safety will also be closely monitored by reviewing any side effects or adverse events that participants may experience. The study aims to provide valuable information on the best treatment options for people newly diagnosed with HIV-1, helping to improve their health outcomes and quality of life.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This means you will either receive the combination of doravirine and islatravir or the combination of bictegravir, emtricitabine, and tenofovir alafenamide. This assignment is done by chance, like flipping a coin.

2 medication administration

If you are in the group receiving doravirine and islatravir, you will take a film-coated tablet containing 100 mg of doravirine and 0.25 mg of islatravir once daily by mouth.

If you are in the group receiving bictegravir, emtricitabine, and tenofovir alafenamide, you will take a film-coated tablet containing 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide once daily by mouth.

3 duration of treatment

You will continue taking the assigned medication daily for a period of 48 weeks. During this time, your health and response to the medication will be closely monitored.

4 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effectiveness of the treatment. These check-ups will include blood tests to measure the amount of HIV-1 in your blood and to check your overall health.

5 end of study evaluation

At the end of the 48-week period, a final evaluation will be conducted to assess the effectiveness and safety of the treatment. This will include a review of your health records and any side effects you may have experienced.

Who Can Join the Study?

  • The person must be at least 18 years old and can be of any sex or gender.
  • The person must have HIV-1 and a certain level of the virus in their blood, specifically 500 copies/mL or more at the time of screening.
  • The person must not have taken any antiretroviral therapy (ART) before. This means they have not used any medication to treat their HIV-1 infection.
  • If the person is a female who can have children, she must not be pregnant or breastfeeding. She must also agree to use a reliable method of birth control or not have heterosexual intercourse during the study.

Who Cannot Join the Study?

  • Patients who are not infected with HIV-1 cannot participate. HIV-1 is a type of virus that affects the immune system.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or groups that the study is focusing on.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups that need special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Hospital Universitario Ramon Y Cajal Madrid Spain
Hospital General Universitario De Elche Elche Spain
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier De Tourcoing Tourcoing France
Assistance Publique Hopitaux De Paris Creteil France
Assistance Publique Hopitaux De Paris Paris France
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Ludwig Maximilian University Of Munich Munich Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Assistance Publique Hopitaux De Paris Paris France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nice Nice France
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Berlin Germany
Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wroclaw Poland
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy
ASST Fatebenefratelli Sacco Milan Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
ICH Study Center GmbH & Co. KG Hamburg Germany
Wojewodzki Szpital Zakazny W Warszawie SPZOZ Warsaw Poland
Hospital Universitario Virgen De La Victoria Malaga Spain
Htliskrx Vdww dthxbrhd Barcelona Spain
Ayttrcnbn Udw Amsterdam The Netherlands
Atzptatpcn Pkgvetlw Hnomikei Da Pmfao Paris France
Aiqvzcdiy Utk Amsterdam The Netherlands
Fnqlblzfk Pthz Ly Ilipgqxsjmjta Bazuxmizv Drt Hwuibubi Uxdomnvbmbhzo Lb Pqo Madrid Spain
Hzxtdomv Ueoorponlkltf Hlfnzvyg Tongw y Pntywe Ikrrngue Cuyihg djahicvwrmbsytowv (shpp Badalona Spain

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

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
06.03.2023
Germany Germany
Not yet recruiting
06.03.2023
Italy Italy
Not yet recruiting
06.03.2023
Poland Poland
Not yet recruiting
06.03.2023
Spain Spain
Not yet recruiting
06.03.2023
The Netherlands The Netherlands
Not yet recruiting
06.03.2023

Trial locations

Doravirine/Islatravir is a combination of two medications used to treat HIV-1 infection. Doravirine helps to block the virus from multiplying in the body, while Islatravir works by interfering with the virus’s ability to reproduce. Together, they help to lower the amount of HIV in the blood, which can improve the immune system and reduce the risk of developing HIV-related illnesses.

Bictegravir/Emtricitabine/Tenofovir Alafenamide is another combination medication used in the treatment of HIV-1 infection. Bictegravir helps to prevent the virus from multiplying, while Emtricitabine and Tenofovir Alafenamide work by blocking the virus’s ability to reproduce. This combination helps to reduce the amount of HIV in the blood, supporting the immune system and decreasing the likelihood of HIV-related health issues.

HIV-1 Infection – Human Immunodeficiency Virus type 1 (HIV-1) infection is a viral condition that targets the immune system, specifically the CD4+ T-cells, which are crucial for immune response. The virus replicates within these cells, leading to their gradual depletion. As the infection progresses, the immune system becomes increasingly compromised, making the body more susceptible to opportunistic infections and certain cancers. The progression of HIV-1 infection can vary, but without intervention, it typically advances through stages, starting from acute infection to chronic infection, and eventually to acquired immunodeficiency syndrome (AIDS). During the chronic phase, the virus continues to multiply at lower levels, often without symptoms, but it can still be transmitted to others. Over time, the persistent viral activity and immune system damage can lead to significant health issues.

Trial ID:
2022-502099-22-00
Protocol code:
MK-8591A-053
Trial Phase:
Therapeutic confirmatory (Phase III)

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