Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02788175
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2016-05-28
Brief Title:
Vedolizumab Anti-alpha4beta7 in Subjects With HIV Infection Undergoing Analytical Treatment Interruption
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Exploratory Open-Label Study of Vedolizumab Anti-alpha4beta7 Antibody in Subjects With HIV Infection Undergoing Analytical Treatment Interruption
Status:
COMPLETED
Status Verified Date:
2019-03-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 participants 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
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 participants 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
Detailed Description:
While combination antiretroviral therapy cART has improved the clinical outcome for HIV-infected individuals persistence of viral reservoirs in the peripheral blood and lymphoid tissues remains a hurdle to complete eradication of virus and cure of the infection The concept that HIV preferentially infects discrete subsets of CD4 T cells underscores the need to develop therapeutics that exploit specific cell-virus interactions T cells expressing integrin alpha4beta7 not only regulate migration into the gut associated lymphoid tissue GALT but also concomitantly bind HIV placing them in a prime position to disseminate HIV throughout the tissue Previously it has been shown that the HIV envelope protein gp120 binds to alpha4beta7 on CD4 T cells in vitro alpha4beta7high CD4 T cells are highly susceptible to productive HIV infection in vitro and the administration of anti-alpha4beta7 monoclonal antibody mAb prevents andor delays transmission of SIV upon repeated challenges and preserves CD4 T cells in rhesus macaques Furthermore it has been demonstrated that administration of anti-alpha4beta7 mAb in SIV-infected rhesus macaques receiving cART suppresses plasma viremia for extended periods following discontinuation of cART collectively suggesting that sustained virologic remission in the absence of cART may be achieved via direct targeting of alpha4beta7 integrin It is well established that the vast majority of HIV-infected individuals treated with cART experience plasma viral rebound within weeks of cessation of therapy Considering that current research on the treatment of HIV-infected individuals has been heavily focused on developing strategies aimed at achieving sustained virologic remission in the absence of cART it is of great interest to investigate whether administration of anti-alpha4beta7 mAb can prevent plasma viral rebound and allow durable suppression of viral replication in HIV infected individuals after discontinuation of cART We propose to examine the effect of vedolizumab an FDA approved anti-alpha4beta7 mAb for the treatment of ulcerative colitis and Crohns disease on plasma viral rebound in HIV-infected individuals following analytical treatment interruption ATI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-I-0118 | None | None | None |