Active not recruitingOBSERVATIONAL

A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/

This study is gathering information about a new HIV medication called Doravirine (DOR) in people living with HIV across Europe. Researchers want to see how effective it is in real-life situations over a 12-month period. They will also look at how often people stop taking the medication and if the HIV virus develops resistance to it. The study will analyse existing medical records from 500 patients at several clinics. This includes people who are new to HIV treatment, those who are switching from other treatments, and some who have specific types of HIV that have developed resistance to certain medications. The aim is to understand how this medication performs for different groups of people.

At a glance

Status

Active not recruiting

Sponsor

NEAT ID Foundation

Enrolment target

500

Start

10 Oct 2022

Estimated completion

01 May 2026

HIV I Infection

What is this study about?

This study is exploring how a new medication for HIV, called Doravirine (DOR), works for people who are already using it in Europe. HIV, or Human Immunodeficiency Virus, can be managed with treatments, and new options are always being developed. Doravirine is one such medication.

The main goal is to understand how effective Doravirine is in everyday clinical practice. Researchers will also look at how many people continue taking it over a year and if the virus changes to become resistant to the drug. This information is important because it helps doctors and patients make informed decisions about HIV treatment.

To do this, the study will collect existing medical information from 500 patients across several clinics in Europe. Patients are grouped based on their HIV treatment history and whether their virus has shown any resistance to similar drugs in the past. This includes people new to HIV treatment, those switching from other treatments, and some with specific resistance profiles, to get a broad understanding of how Doravirine works for different individuals.

Key takeaways

This study reviews existing patient data about the HIV drug Doravirine (DOR).
It aims to understand how DOR performs in real-world settings over 12 months.
Researchers will assess effectiveness, how often patients continue treatment, and viral resistance.
No active patient participation is required; your medical records are reviewed.
Information from 500 patients across Europe will be used, from different treatment backgrounds.
The findings will help improve understanding and treatment choices for people with HIV.

Who may be eligible?

To be included in this study, you must be an adult (18 years or older) living with HIV, and you must have already started taking Doravirine. Your doctor must have also done a resistance test for your HIV before you started taking Doravirine.

There are also specific criteria depending on which group you fit into. For example, some groups might include people new to HIV treatment, while others are for those who have been on different treatments already. Some groups also look at whether your virus has developed any resistance to similar medications.

However, you will not be included if there isn't a resistance test available from before you started Doravirine, or if you are already involved in another Doravirine study. Also, if Doravirine is part of your fourth or later treatment combination, you likely wouldn't be included in one of the main groups.

Quick self-check

Are you 18 years old or older?
Are you living with HIV?
Have you started taking Doravirine (DOR)?
Was a test for HIV drug resistance done before you started Doravirine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study will not involve you actively doing anything as a patient. Instead, it will look back at your existing medical records if you meet the criteria. This means there are no extra clinic visits, no new medications to take, and no special tests you need to undergo for this study. The researchers will simply review information that has already been collected as part of your regular medical care over a 12-month period since you started Doravirine.

Potential risks and benefits

Since this study is simply looking at existing medical records, there are no direct risks or benefits to you as an individual. You won't be asked to do anything differently. The potential benefit is that the information gathered will help doctors and patients understand more about how Doravirine works in real-world settings, which can improve future HIV care. Because your participation is based on existing data, you are not actively participating in a way that would allow you to withdraw your consent, as the data has already been collected.

Locations (19)

Institute Of Tropical Medicine Antwerp
Antwerp, Belgium
Saint-Pierre University Hospital
Brussels, Belgium
Hospital Center University De Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
CHU Nantes University Hospital
Nantes, France
Hospital Center University De Nice
Nice, France
Bichat-Claude Bernard Hospital
Paris, France
Hopital Universitaire Pitie-Salpetriere
Paris, France
Hospital Saint Antoine
Paris, France
Lariboisière Hospital
Paris, France
Saint-Louis Hospital
Paris, France
St Louis Hospital
Paris, France

+7 more sites — see the official record for the full list.

Common questions

What is Doravirine (DOR)?

Doravirine is a medication used to treat HIV infection.

Will I need to do anything extra for this study?

No, this study only looks at existing medical records, so you won't need to do anything different or have extra appointments.

How long will the study follow patients?

The study will look at patient information for 12 months after they started taking Doravirine.

What kind of information are they looking for?

They want to know how well the medication works, if people continue taking it, and if the virus becomes resistant to it.

Is my privacy protected in this study?

Yes, patient records are handled with strict privacy to protect your identity and personal health information.