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

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 may have a repeat lumbar puncture.

After the Week 48 visit, their participation is finished.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

DRUG

Darunavir

Orally-administered medication approved for HIV treatment. MOA is as a protease inhibitor. Dose is 600mg twice daily.

DRUG

Ritonavir

Orally-administered, FDA-approved medication for HIV treatment. Used in combination with darunavir. Dose is 100mg twice daily.

DRUG

Dolutegravir

Orally-administered, FDA-approved medication to treat HIV. It acts as an integrase inhibitor. Dose is 50mg once daily.

DRUG

Tenofovir alafenamide (TAF)

Orally-administered, FDA-approved medication used to treat HIV. It acts as a nucleoside reverse transcriptase inhibitor. Dose is 25mg once daily.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  lead NIH

Principal Investigators

• Avindra Nath, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2022-11-17

Completion

2023-05-09

FDA Drug

Yes

Countries

• United States

Study Locations