HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
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.
Objectives:
- To learn how drugs usually taken for HIV infection affect people with Amyotrophic Lateral
Sclerosis (ALS).
Eligibility:
- Adults at least 18 years old with ALS and high levels of HERV-K but no HIV.
Design:
- Interested participants can contact the study team and, if eligible, the study team will
arrange for a screening blood draw to determine the HERV-K level.
- Participants with a high HERV-K level will be screened with medical history, physical
exam, questionnaires, nerve conduction test, lumbar puncture, and blood and breathing
tests.
- After screening, participants will start taking the 4 study drugs.
- Participants will have up to 12 study visits over a period of 72 weeks. After starting
study drugs, they will have study visits at Weeks 1 and 4 and then every 4 weeks until
Week 28. They will be asked how they are feeling and have an exam and blood drawn. At 3
visits, they will have tests of nerve conduction, breathing, and their ALS symptoms.
- At Week 24, they will stop taking the study drugs and have a repeat lumbar puncture.
- After the Week 48 visit, their participation is finished.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)