A Phase 3 interventional study of Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq) in Amyotrophic Lateral Sclerosis and ALS, sponsored by Macquarie University, Australia. Terminated at 7 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Macquarie University, Australia · Phase 3, Interventional, and Treatment
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.
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 12 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Macquarie University, Australia is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Time frame: Duration of the study plus 7 days
Plan to share: Yes — Contact Chief Investigator for access information
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Macquarie University, Australia