Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis

Study Purpose:

To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo

Study Status:



Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:

Dolutegravir, Abacavir and Lamivudine, Placebo




Phase 3

Study Chair(s)/Principal Investigator(s):

Julian Gold, MD, FFPHM, Macquarie University

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Ammar Al-Chalabi, PhD, FRCP / email hidden; JavaScript is required / +44 20 7848 5174

Full Study Summary:

This Randomised Double-Blind Placebo Controlled trial seeks to investigate whether the combination medicine Triumeq (dolutegravir 50mg, abacavir 600mg, lamivudine 300mg), already sold in Australia for HIV treatment is effective in delaying progression of theAmyotrophic Lateral Sclerosis (ALS) disease and if it is safe and well tolerated in patients with ALS. This medication is very commonly prescribed for patients with HIV. The secondary aim of this study is to assess patient's health outcomes whilst taking this medication for their ALS.

Study Sponsor:

Macquarie University, Australia

Estimated Enrollment:


Estimated Study Start Date:

02 / 24 / 2022

Estimated Study Completion Date:

07 / 01 / 2026

Posting Last Modified Date:

09 / 29 / 2022

Date Study Added to neals.org:

01 / 18 / 2022

Minimum Age:

18 Years

Maximum Age:


Inclusion Criteria:

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. 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 baseline and be non-lactating. Women of childbearing potential are defined as females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period).

8. For participants taking antacids (regularly or as required), participant is willing and able to avoid taking antacids for at least 2 hours before and 6 hours after Triumeq

Exclusion Criteria:

1. People who are HLA-B*5701 positive

2. Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients

3. Safety Laboratory Criteria at screening:

- ALT ≥ 5 times upper limit of normal (ULN)

- AST ≥ 3 times ULN

- Bilirubin ≥ 1.5 times ULN

- Creatinine clearance < 30 mL / min

- Platelet concentration of < 100 x109 per L

- Absolute neutrophil count of < 1x109 per L

- Haemoglobin < 100 g/L

- Amylase & lipase ≥ 2 times ULN

- Lactate ≥ 2 times ULN

4. Moderate to severe hepatic impairment, as defined by local clinical guidelines

5. Presence of HIV antibodies at screening

6. Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C

7. Presence of Hepatitis B core or surface antigen at screening

8. Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening

9. Use of NIV ≥22 h per day or having a tracheostomy

10. 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 Australia

11. Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness

12. Taking medication contraindicated with Triumeq: Dofetilideor Fampridine (dalfampridine)

The University of Sydney - Brain and Mind Centre | Recruiting

Matthew Kiernan / +61291144250 / email hidden; JavaScript is required

Principal Investigator : Matthew Kiernan, DSc, MBBS, FRACP

Camperdown, New South Wales 2050

MQ Health Neurology | Recruiting

Dominic B Rowe, MBBS, FRACP / +61298123720 / email hidden; JavaScript is required

Principal Investigator : Dominic B Rowe, MBBS, FRACP

North Ryde, New South Wales 2109

Sunshine Coast University Hospital | Not yet recruiting

Antony Winkel, MBBS, PhD / 0752020000 / email hidden; JavaScript is required

Birtinya, Queensland 4575

Royal Brisbane and Women's Hospital | Recruiting

Robert Henderson / +61736468111 / email hidden; JavaScript is required

Principal Investigator : Robert Henderson, MBBS, PhD, FRACP

Herston, Queensland 4029

Flinders Medical Centre | Recruiting

David Schultz / +61882044187 / email hidden; JavaScript is required

Principal Investigator : David Schultz, MBBS, FRACP

Bedford Park, South Australia 5042

Launceston General Hospital | Recruiting

Lauren Giles / +61367776001 / email hidden; JavaScript is required

Principal Investigator : Lauren Giles, MBBS, FRACP

Launceston, Tasmania 7250

Calvary Health Care Bethlehem | Recruiting

Sarah Lee / +61395962853 / email hidden; JavaScript is required

Principal Investigator : Sarah Lee, MBBS, FRACP

Parkdale, Victoria 3195

The Perron Institute | Recruiting

Merrilee Needham / +61864570209 / email hidden; JavaScript is required

Principal Investigator : Merrilee Needham, MBBS, PhD, FRACP

Nedlands, Western Australia 6009