Safety and Tolerability of Antiretroviral (Triumeq) in Patients With Amyotrophic Lateral Sclerosis (ALS).
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Neuroscience Trials Australia
Collaborators:
Calvary Health Care Bethlehem Macquarie University, Australia The University of Sydney - Brain and Mind Centre Westmead Hosptial