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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Sylvia
Wilczynska
+44 (0)20 7848 0532
sylvia.1.wilczynska@kcl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Amyotrophic Lateral Sclerosis (ALS)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Amyotrophic lateral sclerosis (ALS) is a progressive motor neuron disease. Unfortunately, there are limited medications available for ALS. The only available treatment is riluzole, which tends to provide only minimal benefit. Therefore, there is a high need for further research using other medications, to help improve the options for treatment for this disease.
There has been laboratory research that suggests that a virus called an endogenous retrovirus may be the cause or trigger for ALS in some people. This virus may be of the same family (although quite different) to the virus that causes HIV (also called ‘AIDS’). Researchers are intending to test if an anti-viral medication that is a very effective treatment for HIV, may also be effective for people who have ALS.
Triumeq, commonly prescribed for HIV treatment, is an antiviral medication that is a combination of three medications: dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg. Triumeq is approved by the Therapeutic Goods Administration (TGA) to treat HIV patients. However, it is not approved to treat ALS. Therefore, it is an experimental treatment for ALS.
The aim of this study is to determine whether Triumeq is effective at delaying the progression of ALS, and whether it is safe and well-tolerated in patients with ALS. The Lighthouse study demonstrated Triumeq to be safe and well tolerated in people with ALS.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 13/02/2024:
1. Age ≥ 18 years at the time of screening
2. Diagnosis of ALS according to the Gold Coast Criteria
3. Capable of providing informed consent and complying with trial procedures
4. TRICALS risk profile > -6.0 and < -2.0
5. 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
6. 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. Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, e.g. combined (oestrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception
7. 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. Women of childbearing potential are defined as females who are fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
8. For participants taking antacids (regularly or as required), the participant is willing and able to avoid taking antacids for at least 6 hours before and 2 hours after Triumeq
9. Participants taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.
10. Participants taking taurursodiol supplements (TUDCA) that also contain sodium phenylbutyrate must be willing to stop supplementation 30
You may not be able to take part if:
Current exclusion criteria as of 13/02/2024:1. People who are HLA-B*5701 positive2. Known hypersensitivity to dolutegravir, abacavir or lamivudine, or to any of the excipients3. Safety Laboratory Criteria at screening:3.1. ALT ≥ 5 times upper limit of normal (ULN)3.2. AST ≥ 3 times ULN3.3. Bilirubin ≥ 1.5 times ULN with clinical indicators of liver disease3.4. Creatinine clearance < 30 ml/min3.5. Platelet concentration of < 100 x109 per l3.6. Absolute neutrophil count of < 1x109 per l3.7. Haemoglobin < 100 g/l3.8. Amylase ≥ 2 times ULN3.9. Lactate ≥ 2 times ULN4. Moderate to severe hepatic impairment, as defined by local clinical guidelines5. Presence of HIV antibodies at screening6. Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C7. Presence of Hepatitis B core or surface antigen at screening8. Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening9. Use of NIV ≥22 h per day or having a tracheostomy10. Edaravone dose within 30 days prior to screening. Edaravone is approved by the FDA and in Japan, but remains an investigational product in Europe and Australia11. Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness12. Taking medication contraindicated with Triumeq: dofetilide or fampridine (dalfampridine)13. Taking Tofersen within 3 months prior to screening.
Previous exclusion criteria:1. People who are HLA-B*5701 positive2. Known hypersensitivity to dolutegravir, abacavir or lamivudine, or to any of the excipients3. Safety Laboratory Criteria at screening:3.1. ALT ≥ 5 times upper limit of normal (ULN)3.2. AST ≥ 3 times ULN3.3. Bilirubin ≥ 1.5 times ULN3.4. Creatinine clearance < 30 ml/min3.5. Platelet concentration of < 100 x109 per l3.6. Absolute neutrophil count of < 1x109 per l3.7. Haemoglobin < 100 g/l3.8. Amylase & lipase ≥ 2 times ULN3.9. Lactate ≥ 2 times ULN4. Moderate to severe hepatic impairment, as defined by local clinical guidelines5. Presence of HIV antibodies at screening6. Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C7. Presence of Hepatitis B core or surface antigen at screening8. Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening9. Use of NIV ≥22 h per day or having a tracheostomy10. Edaravone dose within 30 days prior to screening. Edaravone is approved by the FDA and in Japan, but remains an investigational product in Europe and Australia11. Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness12. Taking medication contraindicated with Triumeq: dofetilideor fampridine (dalfampridine)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Sylvia
Wilczynska
+44 (0)20 7848 0532
sylvia.1.wilczynska@kcl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by King's College London; Macquarie University; Stichting TRICALS Foundation and funded by Efficacy and Mechanism Evaluation Programme; FightMND; Motor Neurone Disease Research Institute of Australia; Treatment Research Initiative to Cure ALS (TRICALS).
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