Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption
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|ClinicalTrials.gov Identifier: NCT02788175|
Recruitment Status : Completed
First Posted : June 2, 2016
Results First Posted : December 16, 2019
Last Update Posted : February 24, 2020
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 test 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Biological: Entyvio (Vedolizumab)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory, Open-Label Study of Vedolizumab (Anti-alpha4beta7 Antibody) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption|
|Study Start Date :||May 28, 2016|
|Actual Primary Completion Date :||March 4, 2019|
|Actual Study Completion Date :||March 4, 2019|
Experimental: HIV-infected Adults on cART
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
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
- Number of Grade 2 or Higher Related Adverse Events [ Time Frame: From the start of the initial infusion until up to 72 weeks. ]The primary endpoint was the number of grade 2 or higher adverse events, including serious adverse events, that were probably or definitely related to vedolizumab.
- Number of Subjects Who Met Criteria to Restart Antiretroviral Therapy Before Week 48 [ Time Frame: From Week 22 until up to 48 weeks. ]The secondary endpoint was defined as number of subjects who experienced plasma viremia following ATI and met criteria to restart cART before week 48 [a confirmed >30% decline in baseline CD4+ T Cell count or an absolute CD4+ T Cell count in the setting of detectable HIV viremia (>40 copies/mL); a sustained (>4weeks) HIV RNA level of > 1000 copies/mL, or any HIV related symptoms or pregnancy.]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788175
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Michael C Sneller, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|