Study on the Effects of Triumeq (Abacavir Sulfate, Lamivudine, Dolutegravir Sodium) in Patients with Amyotrophic Lateral Sclerosis (ALS)

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Triumeq on a disease known as Amyotrophic Lateral Sclerosis (ALS). ALS is a condition that affects the nerve cells in the brain and spinal cord, leading to muscle weakness and loss of muscle control. The study will compare the effects of Triumeq, which is a combination of three active substances: abacavir sulfate, lamivudine, and dolutegravir sodium, with a placebo, which looks and tastes like Triumeq but does not contain the active substances.

The purpose of this study is to see how well Triumeq works in improving the overall survival of people with ALS over a period of 24 months. Participants will be randomly assigned to receive either Triumeq or the placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations or bias.

Throughout the study, participants will have regular check-ups to monitor their health and assess the effects of the treatment. These check-ups will include evaluations of daily functioning, respiratory function, and overall quality of life. The study will also track any side effects or adverse events that may occur. The goal is to gather comprehensive information on how Triumeq affects people with ALS and to determine its safety and effectiveness in treating this condition.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the actual medication, Triumeq, and the other group will receive a placebo. A placebo looks like the real medication but does not contain the active ingredients.

2 medication administration

If you are in the group receiving Triumeq, you will take a film-coated tablet containing abacavir sulfate, lamivudine, and dolutegravir sodium. The dosage is 50 mg/600 mg/300 mg. The medication is taken orally.

The frequency and duration of taking the medication will be explained to you by the study team. It is important to follow the instructions carefully.

3 regular visits

You will have regular visits to the study site. During these visits, your health will be monitored through physical examinations, laboratory tests, and assessments of your daily functioning and respiratory function.

Your cognitive function and quality of life will also be evaluated using specific questionnaires.

4 safety monitoring

Throughout the study, your safety will be closely monitored. This includes checking for any side effects or adverse events that may occur.

If you experience any side effects, it is important to report them to the study team immediately.

5 end of study

The study is expected to last for 24 months or until a minimum of 212 events have occurred. At the end of the study, your overall survival and other health outcomes will be assessed.

You will receive information about the results of the study and any further steps that may be necessary.

Who Can Join the Study?

Must be at least 18 years old at the time of screening.
If taking taurursodiol supplements (TUDCA) that also contain sodium phenylbutyrate, must be willing to stop taking them 30 days before starting the study.
Must have a diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to specific medical guidelines.
Must be able to understand the study and agree to participate by signing a consent form.
Must have a TRICALS risk profile score between -6.0 and -2.0. (This is a specific score used to assess risk in ALS patients.)
If taking Riluzole (a medication for ALS), must be on a stable dose for at least 30 days before the study starts or must have stopped taking it at least 30 days before the study starts.
Women must not become pregnant during the study and for five days after it ends. This can be ensured by being post-menopausal, surgically sterile, using effective birth control, or not having sex that could lead to pregnancy.
Women who can have children must have a negative pregnancy test before starting the study and must not be breastfeeding. They will receive advice on suitable birth control methods, and their menstrual history will be checked at each visit.
If taking antacids (medications that reduce stomach acid), must be willing to avoid taking them for at least 6 hours before and 2 hours after taking the study medication, Triumeq.
If taking taurursodiol supplements (TUDCA) that do not contain sodium phenylbutyrate, participation in the study is allowed.

Who Cannot Join the Study?

Patients who do not have Amyotrophic Lateral Sclerosis (ALS) cannot participate. ALS is a disease that affects nerve cells in the brain and spinal cord.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their interests.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Karolinska University Hospital	Solna	Sweden
University Medical Center Ljubljana	Ljubljana	Slovenia
Beaumont Hospital	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	20.03.2023
Slovenia	Not recruiting	20.03.2023
Spain	Not recruiting	20.03.2023
Sweden	Not recruiting	20.03.2023
The Netherlands	Not recruiting	20.03.2023

Trial locations

Investigated drugs:

Triumeq is a medication used in this clinical trial to evaluate its effectiveness in treating Amyotrophic Lateral Sclerosis (ALS). Triumeq is a combination of three different drugs that work together to help manage the condition. It is typically used to treat HIV, but in this study, researchers are exploring its potential benefits for people with ALS. The goal is to see if Triumeq can help improve overall survival in patients with this condition.

Investigated diseases:

Amyotrophic lateral sclerosis

Amyotrophic Lateral Sclerosis – Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. It leads to the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As the disease progresses, individuals experience muscle weakness and atrophy, leading to difficulties in speaking, swallowing, and eventually breathing. The progression of ALS varies among individuals, but it typically results in increasing disability. Over time, the loss of motor neurons leads to complete paralysis. Despite the loss of muscle function, cognitive abilities are often preserved.

Trial ID:

2024-517054-94-00

NCT ID:

NCT05193994

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Triumeq (Abacavir Sulfate, Lamivudine, Dolutegravir Sodium) in Patients with Amyotrophic Lateral Sclerosis (ALS)

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