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Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption

NCT02788175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-02-24

Study results available
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Summary

Background:

In most people infected with human immunodeficiency virus (HIV), their immune system cannot control HIV infection. They need drugs called combination antiretroviral therapy (cART) to control the HIV. When people stop cART treatment, their immune system cannot control the infection again. They can also become resistant to cART and have lasting side effects. Researchers want to test if the drug vedolizumab is effective at controlling HIV infection without the need for cART.

Objective:

To test if vedolizumab is safe and can control the amount of HIV in the blood when cART is not taken.

Eligibility:

People ages 18-65 who have HIV and are being treated with cART

Design:

Participants will be screened with:

Physical exam

Medical history

Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity.

Blood and urine tests

Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It will include repeats of the screening tests and:

Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white blood cells from the blood. The rest of the blood is returned to the participant.

Neurologic exam: The nerves and reflexes are tested.

First vedolizumab infusion through an arm vein

Participants will have visits every 4 weeks for 30 weeks. These will include:

Vedolizumab infusions

Repeats of baseline tests

Participants will have more visits for blood draws.

Participants will keep taking cART until after the week 22 infusion.

After discontinuing cART at study week 22, participants will be seen every two weeks to monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in between infusion visits and will only take about 1 hour to complete. cART will be restarted if a participant's HIV levels go up to high, or if their CD4 cell counts decreases by too much.

For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. These will include blood tests and a physical exam.

...

Conditions

Interventions

BIOLOGICAL

Entyvio (Vedolizumab)

A humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin with MAdCAM-1, which in turn inhibits the migration of T-lymphocytes across the endothelium into GALT

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael C Sneller, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-28
Primary Completion
2019-03-04
Completion
2019-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788175 on ClinicalTrials.gov