Phase 2CompletedAge-related condition
Safety and Tolerability of Antiretroviral (Triumeq) in Patients With Amyotrophic Lateral Sclerosis (ALS). (Lighthouse)
Phase 2a Open Label Study, Safety and Tolerability of Combination Antiretroviral Therapy (Triumeq) in Participants With Amyotrophic Lateral Sclerosis (ALS) - The Lighthouse Project.
- Sponsor
- Neuroscience Trials Australia (Academic or other)
- Enrollment
- 43 enrolled
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Triumeq
- Ages
- adults, older adults
- Registry
- NCT02868580
Full record on ClinicalTrials.gov
From the registry
This is a phase 2a open label, multicentre design study to investigate the safety of Triumeq in patients with ALS at 24 weeks post treatment. In this phase 2a study the investigators aim to determine whether a combination of anti-retroviral therapy, Triumeq (dolutegravir 50mg, abacavir 600mg, lamivudine 300mg) is tolerated and safe in patients with ALS. As secondary outcomes, ALSFRS-R, ALSQOL, physical examination, neurophysical parameters and respiratory and muscle function will be evaluated. Blood and urine samples will be stored for possible future analysis for viral activity. Subjects will be screened for the study after signing an approved Informed consent document.
Primary outcomes
- Number of participants with treatment related adverse events as defined CTCAE V4.0.
History
Last registry update
Study completion
Primary completion
Started
Registered