Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption
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.
To teste if vedolizumab is safe and can control the amount of HIV in the blood when cART is not taken.
People ages 18-65 who have HIV and are being treated with cART
Participants will be screened with:
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:
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Exploratory, Open-Label Study of Vedolizumab (Anti-alpha4beta7 Antibody) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption|
- To evaluate the safety and tolerability of vedolizumab in HIV-infected individuals prior to and following analytical treatment interruption (ATI). [ Time Frame: Throughout ]
- To evaluate the effect of vedolizumab administration on plasma viral rebound in HIV-infected individuals following ATI [ Time Frame: Throughout ]
|Study Start Date:||May 18, 2016|
|Estimated Study Completion Date:||May 1, 2020|
|Estimated Primary Completion Date:||May 1, 2019 (Final data collection date for primary outcome measure)|
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia and CD4 greater than 450
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02788175
|Contact: Catherine A Seamon, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Michael C Sneller, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|