Lighthouse II study

Korábbi kezelés

• Edaravone dose within 30 days prior to screening
• Taking medication contraindicated with Triumeq: Dofetilide or Fampridine (dalfampridine)
• Taking Tofersen within 3 months prior to screening
• Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening

Más betegség

• Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness
• Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients
• 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
• Presence of Hepatitis B core or surface antigen at screening

Laborértékek

• 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

Egyéb

• People who are HLA-B*5701 positive
• Use of NIV ≥22 h per day or having a tracheostomy

• Age ≥ 18 years at the time of screening
• Participants taking taurursodiol supplements (TUDCA) that also contain sodium phenylbutyrate must be willing to stop supplementaiton 30 days prior randomisation
• Diagnosis of ALS according to the Gold Coast Criteria (Please see Table 1 of Shefner et al Clinical Neurophysiology 2020, also available in Appendix 1)
• 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
• 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
• 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