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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional




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

Brief 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:

  • Participants will be screened with medical history, physical exam, and blood and breathing tests.
  • Visit 2: participants will have medical history, questionnaires, and blood drawn. Their strength will be tested by pushing on a machine. They will blow into a tube that measures the air they can hold in their lungs.
  • After Visit 2, participants will start taking the 4 study drugs twice a day.
  • Participants will have study visits at Weeks 1, 2, and 4, then every 4 weeks until Week 36. They will be asked how they are feeling and have an exam and blood drawn. At 2 visits, they will have tests of strength, breathing, and their ALS symptoms. Some visits may be done at their ALS doctor s office.
  • At Week 24, they will stop taking the study drugs.
  • After the Week 36 visit, their participation is finished.