RecruitingPHASE3INTERVENTIONAL

Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

Living with HIV often means taking daily medication, and while these treatments are very effective, they can sometimes cause side effects over time. This research explores a different approach: a two-pill combination of doravirine and dolutegravir. The study wants to find out if this simpler treatment is just as safe and effective as the current standard three-pill regimens for people with HIV whose virus is already well-controlled. The main goal is to see if this new two-pill option can reduce side effects while keeping the virus suppressed. Participants will either switch to the new treatment or continue their current treatment before switching later, helping researchers compare the different approaches.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Chelsea and Westminster NHS Foundation Trust

Enrolment target

150

Start

17 Aug 2022

Estimated completion

30 Nov 2027

HIV-1-infection

What is this study about?

Imagine you're living with HIV, and thanks to modern medicines, you're doing really well. Your viral load (the amount of virus in your blood) is so low that it can't even be detected, which is fantastic! These treatments, often a combination of three different medicines, have greatly improved the lives of many people with HIV, helping them live longer and healthier.

However, taking any medicine for a long time can sometimes lead to side effects. For example, some people might experience issues like kidney problems, bone thinning, or digestive troubles. Because of this, doctors and researchers are always looking for ways to make HIV treatment even better – aiming for regimens that are just as effective but perhaps have fewer or milder side effects, or are simpler to take.

This study is focused on one such new idea. It's investigating a two-pill combination of medicines called doravirine and dolutegravir. The main question they want to answer is: can switching to this two-pill treatment be just as safe and effective as continuing with the usual three-pill treatments? By finding this out, they hope to offer people living with HIV more options for managing their condition with potentially fewer side effects.

Key takeaways

Exploring a new two-pill HIV treatment (doravirine + dolutegravir).
Aimed at people whose HIV is already well-controlled on current treatment.
Compares the new two-pill regimen to current three-pill treatments.
Hopes to find an option with similar effectiveness but potentially fewer side effects.
Involves regular check-ups, blood tests, and questionnaires over nearly two years.

Who may be eligible?

To join this study, you need to be at least 18 years old and living with HIV. A key requirement is that your current HIV treatment, which usually involves three different medicines, must have been working very well for at least the last six months, meaning your viral load is undetectable.

There are also some important health checks. You can't have certain other health issues, liver or kidney problems, or be pregnant or breastfeeding. Also, if you've previously had problems with similar types of HIV medicines (NNRTI or INSTI drugs) that caused your treatment to fail, you might not be able to join unless specific tests show you wouldn't have resistance to the study drugs. Women who could become pregnant need to be using reliable birth control.

It's important to discuss all your current health conditions and any other medicines you take with the study team, as some combinations might prevent you from participating. They will do a thorough review to make sure the study is a safe option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have HIV?
Has your current three-pill HIV treatment been working very well for at least 6 months (undetectable viral load)?
Are you able to use reliable contraception if you could become pregnant?
Do you have any serious kidney or liver problems that might prevent you from joining?
Have you discussed any past treatment failures or resistance test results with your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned by a computer to one of two groups. Two out of three people will be in the 'early switch' group, meaning you'll stop your current three-pill HIV treatment and start taking the new two-pill combination (doravirine + dolutegravir) right away. You'll take these two pills for about 96 weeks (around 1.8 years).

The other group (one out of three people) will be in the 'delayed switch' group. You'll continue taking your current three-pill treatment for the first 48 weeks (about 11 months). After this, you'll then switch to the new two-pill combination for another 48 weeks. Everyone in the study will have regular check-ups where your viral load will be measured to make sure the treatment is working. You'll also be asked to provide blood and urine samples and fill out questionnaires at the beginning and every 24 weeks to help assess your safety, how well you tolerate the medicine, and your overall quality of life. The total duration of participation will be almost two years for most people.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of switching to a simpler two-pill HIV treatment that might have fewer side effects than your current three-pill regimen, while maintaining good control of your HIV. However, as with any study, there are potential risks. The new treatment might not work as well for you, or you could experience different or unexpected side effects. You would be closely monitored throughout the study to quickly address any issues. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mortimer Market Centre
Verified postcode
London, United Kingdom· Recruiting
Chelsea & Westminster Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'two-pill' treatment compared to a 'three-pill' treatment?

It simply means you take two different medications to treat your HIV, rather than three. The goal is to make treatment simpler and potentially reduce side effects.

Will I know which treatment group I'm in?

Yes, this is an 'open label' study, meaning both you and the study team will know whether you are taking the new two-pill combination or continuing with your current three-pill treatment.

What does 'undetectable viral load' mean?

It means the amount of HIV in your blood is so low that it cannot be measured by standard tests. This is the goal of HIV treatment, and it means you cannot pass the virus on.

What if I experience side effects during the study?

The study team will closely monitor your health throughout. If you experience any side effects, you should report them immediately so they can be managed, and if necessary, changes to your care can be made.

How long will I be in the study?

Most participants will be in the study for about 96 weeks, which is roughly one year and nine months.

How to find out more

Research Regulatory Compliance Manager

chelwest.research@nhs.net 020 3315 6825 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.