Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02429869
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2015-04-24
Brief Title:
Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Impact of Everolimus on HIV Persistence Post Kidney and KidneyPancreas or Liver Transplant
Status:
COMPLETED
Status Verified Date:
2019-10
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:
HIVTR-EVE
Brief Summary:
Zortress everolimus the 40-O-2-hydroxyethyl-derivative of rapamycin is an mTOR inhibitor approved for rejection prophylaxis in kidney transplant recipients mTOR inhibition may favorably impact the HIV viral reservoir and we hypothesize that adding everolimus to the transplant immunosuppressive regimen of HIV positive transplant recipients will decrease HIV persistence in CD4 lymphocytes
Detailed Description:
Open-label single arm study that will enroll antiretroviral-treated HIV-infected adults who are doing well post-liver or post-kidney transplant who are eligible and willing to add everolimus to their immunosuppressive regimen with a target trough level between 3-8 ngml Calcineurin inhibitors will be decreased to obtain a 50 reduction in trough levels with the addition of everolimus Subjects will be maintained on that regimen for 6 months
Biologic specimens for intensive immunology and virology studies will be obtained before during and after exposure to everolimus Samples will be analyzed at screening baseline prior to addition of everolimus and at weeks 8 and 26 while on everolimus and week 52 6 months post everolimus discontinuation
Biologic specimens for intensive immunology and virology studies will be obtained before during and after exposure to everolimus Samples will be analyzed at screening baseline prior to addition of everolimus and at weeks 8 and 26 while on everolimus and week 52 6 months post everolimus discontinuation
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