Amyotrophic Lateral SclerosisPhase 3Lighthouse IIINCT06658977
RolloverTreatment With Triumeq for People With ALS Following the Lighthouse II Trial
A Phase 3 study testing Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq) in people with Amyotrophic Lateral Sclerosis and ALS, run by Macquarie University, Australia at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, ALS
- What is being tested?
- Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesAustralia
- Study dates
- 15 Nov 2024to 3 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Flinders Medical Centre
Bedford Park, S.A., 5042
Calvary Health Care Bethlehem
Caulfield South, Victoria, 3162
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
Launceston General Hospital
Launceston, Tasmania, 7250
The Perron Institute
Nedlands, W.A., 6009
Macquarie University, Neurology
North Ryde, New South Wales, 2109
Neuroscience Research Australia (NeuRA)
Randwick, New South Wales, 2031
About this study
Official title: Open Label Rollover Study of Triumeq in Patients With Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial
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.
Read the 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
- Being tested
- Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
- Keywords
- Lighthouse
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)Drug
One Triumeq tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Triumeq open label | Experimental | Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg ('Triumeq') one tablet daily Receives: Drug: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of the study plus 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 Nov 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Why it stopped: This is a rollover study following the Lighthouse II trial; it was scheduled to stop when the LH II trial was stopped/completed. The LH II trial has been prematurely terminated so, likewise, this study has also now been stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Extension
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macquarie University, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658977
- Sponsor's protocol ID
- MQ2024003
- Acronym
- Lighthouse III
- Status last verified
- Jun 2025
- First submitted
- 23 Oct 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact Chief Investigator for access information
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Rollover Study of Triumeq in Patients With Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial
- ClinicalTrials.gov ID
- NCT06658977
- Acronym / sponsor ID
- Lighthouse III / MQ2024003
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Keywords
- Lighthouse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is a rollover study following the Lighthouse II trial; it was scheduled to stop when the LH II trial was stopped/completed. The LH II trial has been prematurely terminated so, likewise, this study has also now been stopped.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Macquarie University, AustraliaUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label Extension
| Arm | Type | Receives |
|---|---|---|
| Triumeq open label | Experimental | Drug: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg ('Triumeq') one tablet daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)One Triumeq tablet per day | Drug | Triumeq open label |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: Duration of the study plus 7 days
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.
Results and safety
The study was stopped early (reason given: This is a rollover study following the Lighthouse II trial; it was scheduled to stop when the LH II trial was stopped/completed. The LH II trial has been prematurely terminated so, likewise, this study has also now been stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Yes. Contact Chief Investigator for access information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq) in people with Amyotrophic Lateral Sclerosis and ALS, run by Macquarie University, Australia at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This is a rollover study following the Lighthouse II trial; it was scheduled to stop when the LH II trial was stopped/completed. The LH II trial has been prematurely terminated so, likewise, this study has also now been stopped.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: Duration of the study plus 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.