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RolloverTreatment with Triumeq for People with ALS Following the Lighthouse II Trial

PHASE3NOT_YET_RECRUITING

Triumeq is an approved medicine for HIV. The effectiveness of Triumeq in Amyotrophic Lateral Sclerosis (ALS) is being investigated in the Lighthouse II trial. This study aims to assess whether Triumeq is safe and effective at delaying ALS disease progression when given long term.

It is available for participants who have completed the Lighthouse II study. The main measurements are safety, tolerability and survival. The study will go for approximately 2 years.

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Study details:

Treatment options for ALS are very limited and there is a high unmet need for effective treatments. Triumeq targets a known neuron toxic pathway and is currently under investigation in a double blind placebo controlled trial, Lighthouse II. This study will be open to participants who took part in, and were still taking the study drug when they completed the Lighthouse II trial, in Australia and New Zealand.

The nature of the target and the mechanism of action of Triumeq are well understood. Participation in this rollover study is concurrent with standard of care, so participants are not limited in their use of therapies. Participants will be assessed for adverse events, discontinuation of study medication, survival, measures of daily functioning, plus biomarker assessments of blood and urine samples.

Participant contacts may be face to face, or remote, and will be at 3 monthly intervals until approx December 2026 by which time it is anticipated the results of the Lighthouse II study will be available.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Participants diagnosed with ALS according to the Lighthouse II protocol who completed the Lighthouse II trial.

Participants taking Riluzole must be on a stable dose.

Participants taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.

Women must not become pregnant (e.g., post-menopausal, surgically sterile, using highly effective birth control methods or not having potentially reproductive sex) for the duration of the study plus five days; and women of childbearing potential must have a negative urine pregnancy test at baseline and be non-lactating.

For participants taking antacids (regularly or as required), participant is willing and able to avoid taking antacids for at least 6 hours before and 2 hours after the Triumeq dose.

Capable of providing informed consent and complying with the trial procedures.

Exclusion criteria

In the Principal Investigator's opinion, the participant is unlikely to be compliant with the study drug dosing.

People who are HLA-B*5701 positive.

Presence of HIV antibodies at screening

Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C

Presence of Hepatitis B core or surface antigen at screening

Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients.

Moderate to severe hepatic impairment, as defined by local clinical guidelines.

Participation in any other investigational drug trial or using another investigational drug within 5 half-lives of that drug.

Use of NIV ≥22 h per day or having a tracheostomy

Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness

Taking medication contraindicated with Triumeq: Dofetilide or Fampridine (dalfampridine)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-31

Primary completion: 2026-12-31

Study completion finish: 2026-12-31

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06658977

Intervention or treatment

DRUG: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)

Conditions

• Amyotrophic Lateral Sclerosis
• ALS

Image related to Amyotrophic Lateral Sclerosis

Condition: Amyotrophic Lateral Sclerosis, ALS
DRUG: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
Launceston, Tasmania, Australia and more
Sponsor: Macquarie University, Australia

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Launceston General Hospital

Research sites nearby

Select from list below to view details:

Launceston General Hospital
Launceston, Tasmania, Australia
Macquarie University, Neurology
North Ryde, New South Wales, Australia
Neuroscience Research Australia (NeuRA)
Randwick, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Triumeq open label Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg ('Triumeq') one tablet daily	DRUG: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq) One Triumeq tablet per day

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).	The primary endpoint of this trial is whether a patient had any drug related (definite, probable, possible) adverse events over the course of the extension trial. Tolerability is defined as the number of participants discontinuing study medication. Adverse events will be described in terms of relationship to temporary or permanent discontinuation of the study medication.	Duration of the study plus 7 days

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: RolloverTreatment with Triumeq for People with ALS Following the Lighthouse II Trial