Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02741323
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2016-04-13
Brief Title:
Impact of CCR5 Blockade in HIV Kidney Transplant Recipients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Impact of CCR5 Blockade in HIV Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2023-08
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:
Maraviroc MVC is a type of HIV medicine called a CCR5 inhibitor This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant
Detailed Description:
MVC is a CCR5 inhibitor that may have a positive role in modulating the immune response following transplantation The purpose of this study is to evaluate the safety and tolerability of MVC in HIV-infected adults in need of a kidney transplant The study will also evaluate whether using both immunosuppressant drugs and MVC will improve kidney function after a kidney transplant
This study will enroll HIV-infected adults on combination antiretroviral therapy cART who need a kidney transplant At the time of their kidney transplant study participants will be randomly assigned to receive either MVC or placebo as an addition to their cART regimen MVC or placebo will be provided by the study However the HIV medicines in their cART regimens will not be provided by the study Participants will receive MVC or placebo throughout their participation in the study which will be 1 to 3 years depending on when they enroll in the study
Study visits will occur at enrollment Day 0 and post-transplant Weeks 1 2 4 8 13 26 39 52 78 104 130 and 156 Study visits may include a physical examination blood collection lymph node collection urine sample collection and a kidney biopsy During the study participants will also be monitored closely for evidence of drug toxicities HIV treatment failure and rejection
This study will enroll HIV-infected adults on combination antiretroviral therapy cART who need a kidney transplant At the time of their kidney transplant study participants will be randomly assigned to receive either MVC or placebo as an addition to their cART regimen MVC or placebo will be provided by the study However the HIV medicines in their cART regimens will not be provided by the study Participants will receive MVC or placebo throughout their participation in the study which will be 1 to 3 years depending on when they enroll in the study
Study visits will occur at enrollment Day 0 and post-transplant Weeks 1 2 4 8 13 26 39 52 78 104 130 and 156 Study visits may include a physical examination blood collection lymph node collection urine sample collection and a kidney biopsy During the study participants will also be monitored closely for evidence of drug toxicities HIV treatment failure and rejection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 20730 | REGISTRY | DAIDS-ES Registry Number | None |