Triumeq in Amyotrophic Lateral Sclerosis

NCT05193994 | Terminated Phase 3 DMC

• 2 other identifiers: LIGHTHOUSE II2020-005069-15
• Study Type: interventional
• Target: 419
• Locations: 8 countries
• Sites: 28

Brief Summary

To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS

Outcome Measures

Primary Outcomes (1)

• Measure overall survival at 24 months or after a minimum of 212 events

  Overall survival is measured as death from any cause, in participants with ALS at 24 months, or after a minimum of 212 events.

  24 months

Secondary Outcomes (9)

• Measure scoring in the ALS-Functional Rating Scale Revised (ALSFRS-R) at 3 monthly intervals.

  24 months

• Number of participants with abnormal Slow Vital Capacity measured by hand spirometry at 3 monthly intervals

  24 months

• Measure plasma creatinine at 3 monthly intervals

  24 months

• Assign a value using the King's Staging Scale to describe degree of disease advancement over time

  24 months

• Evaluate the incidence of treatment-emergent adverse events

  24 months

Study Arms (2)

Dolutegravir/Abacavir/Lamivudine

EXPERIMENTAL

Combination of Dolutegravir, Abacavir and Lamivudine in a single product/capsule. 4 capsules to be taken orally once daily (all 4 at the same time, each capsule is Dolutegravir 12.5mg, Abacavir 150mg and Lamivudine 75mg). Maximum duration is 24months

Drug: Dolutegravir, Abacavir and Lamivudine

Placebo

PLACEBO COMPARATOR

4 capsules to be taken orally once daily (all 4 at the same time). Maximum duration is 24months

Drug: Placebo

Interventions

Dolutegravir, Abacavir and Lamivudine DRUG

Dolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg.

Also known as: Triumeq

Dolutegravir/Abacavir/Lamivudine

Placebo DRUG

Matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of screening
• Diagnosis of ALS according to the Gold Coast Criteria
• Capable of providing informed consent and complying with trial procedures
• TRICALS risk profile \> -6.0 and \< -2.0
• Those taking Riluzole must be on a stable dose for at least 30 days prior to the baseline visit or must have stopped taking Riluzole at least 30 days prior to the baseline visit
• 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. Highly effective methods of birth control are those with a failure rate of \< 1% per year when employed consistently and correctly, e.g. Combined (oestrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception. For more information, please refer to the HMA CTFG Guidelines: https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01-About\_HMA/Working\_Groups/CTFG/2014\_09\_HMA\_CTFG\_Contraception.pdf?fbclid=IwAR3AY5Ha0ESDyqIBeUaYI9VTFWmx9bbt8NZ-80N-5ME6pkBb1UHvFsTwqlQ
• Women of childbearing potential must have a negative serum pregnancy test at screening and be non-lactating. Patients will be advised regarding appropriate contraception. A menstruation history will be taken at each visit. Women of childbearing potential are defined as females who are fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy (https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01-About\_HMA/Working\_Groups/CTFG/2014\_09\_HMA\_CTFG\_Contraception.pdf?fbclid=IwAR3AY5Ha0ESDyqIBeUaYI9VTFWmx9bbt8NZ-80N-5ME6pkBb1UHvFsTwqlQ)
• 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 Triumeq
• Participant taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.
• Participants taking taurursodiol supplements (TUDCA) that also contain sodium phenylbutyrate must be willing to stop supplementation 30 days prior randomisation.

You may not qualify if:

• People who are HLA-B\*5701 positive
• Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients
• Safety Laboratory Criteria at screening:
• ALT ≥ 5 times upper limit of normal (ULN)
• AST ≥ 3 times ULN
• Bilirubin ≥ 1.5 times ULN with clinical indicators of liver disease
• Creatinine clearance \< 30 mL / min
• Platelet concentration of \< 100 x109 per L
• Absolute neutrophil count of \< 1x109 per L
• Haemoglobin \< 100 g/L
• Amylase ≥ 2 times ULN
• Lactate ≥ 2 times ULN
• Moderate to severe hepatic impairment, as defined by local clinical guidelines
• Presence of HIV antibodies at screening
• Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C

Sponsors & Collaborators

• Macquarie University, Australia: lead
• King's College London: collaborator
• Stichting TRICALS Foundation: collaborator

Study Sites (28)

MQ Health Neurology

North Ryde, New South Wales, 2109, Australia

Location

Neuroscience Research Australia (NeuRA)

Randwick, New South Wales, 2031, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Calvary Health Care Bethlehem

Caulfield South, Victoria, 3162, Australia

Location

The Perron Institute

Nedlands, Western Australia, 6009, Australia

Location

Beaumont Hospital

Dublin, D09V2N0, Ireland

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Dunedin Hospital

Dunedin, 9054, New Zealand

Location

Clinical Trials Unit, Tauranga Hospital

Tauranga, 3112, New Zealand

Location

Wellington Regional Hospital

Wellington, 6021, New Zealand

Location

Univerzitetni klinični center Ljubljana

Ljubljana, 1000, Slovenia

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario y Politecnico la Fe

Valencia, 46026, Spain

Location

Studiecenheten at Akademiskt specialistcentrum

Stockholm, 113 61, Sweden

Location

University of Edinburgh, Anne Rowling Regenerative Nuerology Clinic

Edinburgh, EH16 4SB, United Kingdom

Location

The Walton Centre

Liverpool, L9 7LJ, United Kingdom

Location

University College London Hospital

London, NW1 2PG, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Oxford University Hospital

Oxford, OX3 9DU, United Kingdom

Location

Plymouth University Hospital

Plymouth, PL8 8DH, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Sheffield Teaching Hospital

Sheffield, S5 7AU, United Kingdom

Location

Royal Stoke Hotel

Stoke, ST4 6QG, United Kingdom

Location

Related Publications (1)

• Gold J, Rowe DB, Kiernan MC, Vucic S, Mathers S, van Eijk RPA, Nath A, Garcia Montojo M, Norato G, Santamaria UA, Rogers ML, Malaspina A, Lombardi V, Mehta PR, Westeneng HJ, van den Berg LH, Al-Chalabi A. Safety and tolerability of Triumeq in amyotrophic lateral sclerosis: the Lighthouse trial. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Nov;20(7-8):595-604. doi: 10.1080/21678421.2019.1632899. Epub 2019 Jul 8.

  PMID: 31284774 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

abacavir, dolutegravir, and lamivudine drug combination

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Julian Gold, MD, FFPHM

  Macquarie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised in a 2:1 ratio to receive either triumeq or placebo

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 18, 2022
• Study Start: February 24, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Contact the Chief Investigators for access information.
• Access Criteria: Contact the Chief Investigators for access information.

Locations

IE (1); GB (10); ES (2); SE (1); AU (8); NL (1); SL (1); NZ (4)