Phase
Condition
Scar Tissue
Amyotrophic Lateral Sclerosis (Als)
Myasthenia Gravis (Chronic Weakness)
Treatment
Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants diagnosed with ALS according to the Lighthouse II protocol whocompleted the Lighthouse II trial.
Participants taking Riluzole must be on a stable dose.
Participants taking taurursodiol supplements (TUDCA) can participate in this trialif the supplement does not contain sodium phenylbutyrate.
Women must not become pregnant (e.g., post-menopausal, surgically sterile, usinghighly effective birth control methods or not having potentially reproductive sex)for the duration of the study plus five days; and women of childbearing potentialmust have a negative urine pregnancy test at baseline and be non-lactating.
For participants taking antacids (regularly or as required), participant is willingand able to avoid taking antacids for at least 6 hours before and 2 hours after theTriumeq dose.
Capable of providing informed consent and complying with the trial procedures.
Exclusion
Exclusion Criteria:
In the Principal Investigator's opinion, the participant is unlikely to be compliantwith 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 hadeffective 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 theexcipients.
Moderate to severe hepatic impairment, as defined by local clinical guidelines.
Participation in any other investigational drug trial or using anotherinvestigational 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)
Study Design
Study Description
Connect with a study center
Macquarie University, Neurology
North Ryde, New South Wales 2109
AustraliaSite Not Available
Neuroscience Research Australia (NeuRA)
Randwick, New South Wales 2031
AustraliaSite Not Available
Royal Brisbane and Womens Hospital
Herston, Queensland 4029
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, S.A. 5042
AustraliaSite Not Available
Launceston General Hospital
Launceston, Tasmania 7250
AustraliaSite Not Available
Calvary Health Care Bethlehem
Caulfield South, Victoria 3162
AustraliaSite Not Available
The Perron Institute
Nedlands, W.A. 6009
AustraliaSite Not Available
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