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Antiretroviral Therapy

Antiretroviral Therapy for ALS

Phase 1
Waitlist Available
Led By Avindra Nath, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Duration of disease less than 2 years, or if greater than 2 years, disease progression at a rate that in the judgement of the investigator would allow for completion of the study
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 subspecialty training
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each study visit through week 36
Awards & highlights

Study Summary

This trial is testing whether drugs used to treat HIV can suppress a virus found in some people with ALS.

Who is the study for?
Adults over 18 with ALS and high HERV-K levels, but no HIV. They must be able to consent, follow study procedures, have a caregiver for drug administration, stable neurologist care, and meet specific medical criteria including disease duration and progression.Check my eligibility
What is being tested?
The trial tests if HIV drugs Darunavir, Ritonavir, Dolutegravir & TAF can suppress HERV-K in ALS patients. Participants will take these drugs for 24 weeks with regular check-ups including blood tests and nerve function assessments.See study design
What are the potential side effects?
Potential side effects may include digestive issues (nausea or diarrhea), liver enzyme changes, rash or allergic reactions due to the antiretroviral therapy used in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with the disease for less than 2 years, or if it's been longer, your disease has been getting worse slowly enough for you to finish the study.
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You have been diagnosed with ALS by a neurologist with special training in nerve and muscle conditions, using specific criteria set by a global neurology organization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each study visit through week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and each study visit through week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in HERV-K Level
Secondary outcome measures
The secondary objective of this study is to assess the safety of an antiretroviral regimen of darunavir + ritonavir, dolutegravir, and TAF in patients with ALS.

Side effects data

From 2011 Phase 4 trial • 25 Patients • NCT01232127
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALSExperimental Treatment4 Interventions
20 participants with ALS and a level of HERV-K:RPP30 greater than or equal to 13
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darunavir
2008
Completed Phase 4
~4780
Ritonavir
2005
Completed Phase 4
~2200
Dolutegravir
2018
Completed Phase 4
~5970
Tenofovir alafenamide (TAF)
2019
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,335 Previous Clinical Trials
648,409 Total Patients Enrolled
40 Trials studying Amyotrophic Lateral Sclerosis
18,179 Patients Enrolled for Amyotrophic Lateral Sclerosis
Avindra Nath, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
10 Previous Clinical Trials
5,398 Total Patients Enrolled

Media Library

Darunavir, Dolutegravir, Ritonavir, Tenofovir alafenamide (TAF) (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02437110 — Phase 1
Amyotrophic Lateral Sclerosis Research Study Groups: ALS
Amyotrophic Lateral Sclerosis Clinical Trial 2023: Darunavir, Dolutegravir, Ritonavir, Tenofovir alafenamide (TAF) Highlights & Side Effects. Trial Name: NCT02437110 — Phase 1
Darunavir, Dolutegravir, Ritonavir, Tenofovir alafenamide (TAF) (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02437110 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollees currently being accepted for this research endeavor?

"Affirmative, the online record for this medical trial on clinicaltrials.gov indicates that it is actively recruiting participants as of November 16th 2022. This study was first posted in April 1st 2019 and requires 200 volunteers from 2 different sites."

Answered by AI

Is Ritonavir a safe treatment option for individuals?

"The safety of Ritonavir was judged to be a 1 on our team's scale due to the scarcity of data from Phase 1 trials, which offer minimal insight into efficacy and security."

Answered by AI

To what ailments does Ritonavir deliver relief?

"Ritonavir is a highly effective medication for treating virologically suppressed conditions over 3 months. It has also proven to be beneficial in other medical contexts, such as tenofovir treatment failure and compensated liver disease."

Answered by AI

Could you elucidate other investigations that have focused on Ritonavir?

"At the moment, 112 studies are examining Ritonavir where 34 of them have reached phase 3. The trials for this specific immunomodulator are available at various medical centres across 2320 locations in Miami and beyond."

Answered by AI

How many individuals are currently participating in this clinical research?

"Affirmative. The information available on clinicaltrials.gov demonstrates that this experiment is presently recruiting participants, which were first listed on April 1st 2019 and modified lastly in November 16th 2022. Two sites are taking part in the research where 200 subjects need to be enrolled."

Answered by AI
~21 spots leftby Mar 2025