HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Quick Info:

Status:
Ongoing, But Not Recruiting
Estimated Enrollment:
20
Phase:
1
Treatment Type:
Trial Type:
Open Label, no masking
Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
N/A
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
N/A
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

2/15/2018No significant updates
1/11/2018No significant updates
1/5/2018No significant updates
10/11/2017No significant updates
7/11/2017No significant updates
5/16/2017No significant updates
4/24/2017No significant updates
4/24/2017No significant updates
1/13/2017No significant updates
10/6/2016Status Updated: Trial on Hold According to Investigators
9/2/2016No significant updates
8/9/2016No significant updates
5/12/2016No significant updates.
3/9/2016Recruitment status updated (enrolling by invitation only).
5/20/2015Recruitment status and location updated.
5/8/2015Clinical trial added.

Locations:

National Institutes of Health Clinical Center 9000 Rockville Pike, Bethesda, 20892

Other Information:

Purpose: Background: Some people with Amyotrophic Lateral Sclerosis (ALS) have a high level of the virus HERV-K in their blood. Researchers do not think this virus causes ALS. But they don t know why some people with ALS have a high level of it. They want to know if HERV-K can be suppressed by drugs that are used to treat HIV infection. Objective: To learn how drugs usually taken for HIV infection affect people with Amyotrophic Lateral Sclerosis (ALS).
Eligibility: Enrolling by invitation only. Adults at least 18 years old with ALS and high levels of HERV-K but no HIV. No healthy volunteers.
Details: Inclusion Criteria: -Age 18 years or older at the time of the screening visit. -Able to provide informed consent and comply with study procedures. -ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial revised criteria31 as determined by a neurologist with neuromuscular subspecialty training. -Detectable plasma HERV-K gag RNA transcript at a minimum of 1000 copies/ml as measured by quantitative PCR at the screening visit. -Vital capacity at least 60% of predicted value for gender, height and age at the screening visit -If taking riluzole, must be on a stable dose for at least 30 days prior to the screening visit, or stopped taking riluzole at least 30 days prior to the screening visit. -Subject has a competent caregiver who can and will be responsible for administering study drug. If there is no caregiver, another qualified individual must be available to do this. -Subject has established care with a neurologist at a specialized ALS clinic and will maintain this clinical care throughout the study.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 5/5/2015
ClinicalTrials.gov ID: NCT02437110
Trial Protocol as Published on Clinicaltrials.gov: