Clinical trial: Safety and Tolerability of Antiretroviral (Triumeq) in Patients With Amyotrophic Lateral Sclerosis (ALS). (NCT02868580)

Eligibility criteria:
Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria to be eligible to participate in
        this study:

          -  Age 18-75 years at the time of the screening visit

          -  Able to provide informed consent and comply with study procedures

          -  Sporadic ALS diagnosed as probable, laboratory-supported probable or definite
             according to the World Federation of Neurology El Escorial revised criteria as
             determined by a neurologist with neuromuscular sub-specialty training

          -  Diagnosis <24 months from date of enrolment

          -  (Forced) Vital capacity at least 60% of predicted value for gender, height and age at
             the screening visit

          -  Must be on a stable dose of riluzole for at least 30 days prior to the screening
             visit.

          -  Subject has established care with a neurologist at one of the four specialized ALS
             clinics involved in the study and will maintain this clinical care throughout the
             study.

          -  Subjects can participate in clinical registries, but will be excluded to this protocol
             if they are participating in a clinical trial involving additional or investigative
             treatment exposure.

        Exclusion Criteria:

        A participant will be excluded if he or she has any of the following:

          -  Dependence on mechanical ventilation at the time of screening

          -  Gastrostomy at the time of screening

          -  Absence of Upper Motor Neuron Signs

          -  Participation in any other investigational drug trial or using investigational drug
             (within 12 weeks prior to screening)

          -  Known hypersensitivity to dolutegravir, abacavir or lamivudine, or to any of the
             excipients

          -  Presence of the HLA-B*5701 allele at screening

          -  Presence of a monogenic cause of ALS (e.g. known mutation in SOD1, expansion in
             c9orf72 etc.)

          -  History of positive test or positive result at screening for HIV

          -  Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for
             Hepatitis C virus (HCV) therapy during the study*;

          -  Women must not be able to become pregnant (post menopausal for >1 year, surgically
             sterile, adequate contraception) or breastfeed for the duration of the study. Women of
             childbearing potential must have a negative pregnancy test at screening and be
             non-lactating

          -  Other interventional clinical trial

          -  Subject is taking medication contraindicated with Triumeq. Dofetilide (or pilsicainide
             [available in Japan]) is prohibited as DTG may inhibit its renal tubular secretion
             resulting in increased dofetilide concentrations and potential for toxicity.

          -  Presence of any of the following clinical conditions at the time of screening:

        Drug or alcohol abuse Unstable medical disease (such as unstable angina or chronic
        obstructive pulmonary disease), or active infectious disease (such as Hepatitis B or C or
        tuberculosis), or current malignancy Unstable psychiatric illness defined as psychosis or
        untreated major depression within 90 days of the screening visit. This exclusion criteria
        is based on a prior psychiatric diagnosis that is unstable as determined by the subject's
        treating Psychiatrist Dementia as previously diagnosed by a medical practitioner

        • Safety Laboratory Criteria at the screening visit: Alanine aminotransferase (ALT) >5
        times the upper limit of normal (ULN), OR ALT >3xULN Total bilirubin, lactate,
        triglycerides, amylase, or lipase greater than 2.0 times the upper limit of normal Subject
        has creatinine clearance of <50 mL/min via Cockroft-Gault method Subjects with moderate to
        severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
        Absolute neutrophil count of < 1 x 109/L Platelet concentration of < 100 x 109/L
        Haemoglobin < 100g/L
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment