NCT06658977

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

Open Label Rollover Study of Triumeq in Patients With Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Macquarie University, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Amyotrophic Lateral Sclerosis
• ALS

Interventions

Type	Name	Description
DRUG	Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)	One Triumeq tablet per day

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-06-03
• Completion: 2025-06-03
• First posted: 2024-10-26
• Last updated: 2025-06-08

Locations

7 sites across 1 country: Australia