Study on the Effectiveness of Doravirine and Dolutegravir for People with HIV Switching Antiretroviral Therapy

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What is this study about?

This clinical trial is focused on studying the treatment of HIV, a virus that attacks the body’s immune system. The study will use a combination of two medications: doravirine and dolutegravir sodium. Doravirine is also known by its code name MK-1439. These medications are taken as film-coated tablets and are part of a class of drugs known as antiretroviral therapy, which helps control the virus in people living with HIV.

The purpose of the study is to evaluate how effective it is to switch from a standard three-drug antiretroviral therapy to a two-drug therapy using doravirine and dolutegravir sodium in people who already have an undetectable viral load, meaning the virus is not currently detectable in their blood. Participants in the study will take these medications orally for a period of up to 96 weeks. During this time, the study will monitor the participants’ viral load at various intervals to ensure it remains undetectable, as well as assess the safety and tolerability of the treatment.

Throughout the study, participants will have their health closely monitored, including regular checks of their immune system’s health through CD4 counts, which measure a type of white blood cell that is important for fighting infections. The study will also track any side effects or adverse events that may occur, and participants will be asked to complete questionnaires about their quality of life and satisfaction with the treatment. The goal is to determine if this two-drug therapy is a safe and effective option for maintaining control of HIV in people who are already successfully managing the virus with their current treatment.

1 joining the study

Upon joining the study, you will be assessed to ensure you meet the eligibility criteria. This includes being HIV-1 infected, aged 18 or older, and having been on a stable and suppressive triple combination antiretroviral therapy (cART) for at least six months.

You must not have any resistance to the medications doravirine or dolutegravir, and there should be no laboratory abnormalities or medical conditions that could prevent participation.

2 medication administration

You will switch from your current therapy to a dual therapy consisting of Pifeltro (100 mg doravirine) and Tivicay (50 mg dolutegravir).

Both medications are taken orally in the form of film-coated tablets. The exact dosage and frequency will be provided by the study team.

3 monitoring and assessments

Your health and the effectiveness of the treatment will be monitored regularly. This includes checking your HIV viral load at weeks 24, 48, 72, and 96 to ensure it remains below 50 copies/ml.

Safety and tolerability will be assessed through the occurrence of any adverse events, changes in your CD4 count, and other health indicators.

4 completion of questionnaires

You will be asked to complete several questionnaires at weeks 0, 24, 48, 72, and 96. These include the EuroQoL Questionnaire, the Patient Treatment Satisfaction Questionnaire, and the Pittsburgh Sleep Questionnaire.

These questionnaires help assess your quality of life, treatment satisfaction, and sleep patterns during the study.

5 end of study

The study is expected to conclude by November 30, 2027. At the end of the study, a final assessment will be conducted to evaluate the overall efficacy and safety of the dual therapy.

Your participation will contribute to understanding the effectiveness of switching to doravirine and dolutegravir dual therapy in maintaining an undetectable viral load.

Who Can Join the Study?

Must be HIV-1 infected and at least 18 years old.
Must have been on a stable and effective triple cART (combination antiretroviral therapy) for at least 6 months. This treatment can include the medications doravirine (DOR) and/or dolutegravir (DTG).
Must not have any signs of resistance to the medications DOR or DTG. Resistance means the virus is not affected by the medication.
Must not have any laboratory issues, medical or psychiatric conditions, or alcohol/drug use that the study team thinks would prevent participation.
Women who can become pregnant and are sexually active must use a reliable form of birth control that prevents ovulation, such as:
- Implant
- Progesterone injection
- Intra-uterine device or system
- Oral hormonal contraception
Men who are sexually active and have partners who can become pregnant must use a reliable method of birth control, such as a male condom or have had a sterilization procedure confirmed before joining the study.

Who Cannot Join the Study?

Patients with a detectable viral load cannot participate. This means if the virus is found in your blood, you are not eligible.
Patients who are not currently on ART (antiretroviral therapy) are excluded. ART is a treatment for HIV that helps control the virus.
Patients who are not on a stable ART regimen for at least 6 months are not eligible. A stable regimen means you have been taking the same HIV medication without changes for at least 6 months.
Patients with a history of resistance to doravirine or dolutegravir cannot participate. Resistance means the virus does not respond to these medications.
Patients with any other significant health conditions that might interfere with the study are excluded. This means if you have other serious health issues, you may not be eligible.
Pregnant or breastfeeding women cannot participate. This is to ensure the safety of the mother and child.
Patients who are participating in another clinical trial are not eligible. This is to avoid interference with the study results.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Azienda Sanitaria Locale Citta Di Torino	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

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

Dolutegravir is another medication used in the treatment of HIV. It helps to control the infection by preventing the virus from multiplying. By doing so, it helps to reduce the amount of HIV in the body, which can help the immune system to work better and lower the chances of getting complications related to HIV.

Investigated diseases:

HIV infection

Human Immunodeficiency Virus (HIV) Infection – 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 progresses through several stages, starting with acute infection, where flu-like symptoms may appear. This is followed by a chronic stage, where the virus multiplies at low levels and may not cause symptoms. Without treatment, HIV can advance to acquired immunodeficiency syndrome (AIDS), the most severe phase, where the immune system is badly damaged. During this stage, individuals become vulnerable to opportunistic infections and certain cancers.

Trial ID:

2023-509751-14-03

Protocol code:

CW004

NCT ID:

NCT04892654

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Doravirine and Dolutegravir for People with HIV Switching Antiretroviral Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?