Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02990312
Status:
WITHDRAWN
Last Update Posted:
2019-12-16
First Post:
2016-11-21
Brief Title:
Impact of Sirolimus and Maraviroc on CCR5 Expression and the HIV-1 Reservoir in HIV-infected Kidney Transplant Recipients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Effect of Sirolimus Plus Maraviroc on the Expression of Chemokine Receptor 5 CCR5 and the HIV-1 Viral Reservoir in HIV-Infected Renal Transplant Recipients
Status:
WITHDRAWN
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this proof of concept pilot study is to determine whether the unique combination of the human immunodeficiency virus HIV co-receptor antagonist Maraviroc and the mammalian target of rapamycin mTOR inhibitor Sirolimus in HIV-infected kidney transplant recipients has an impact on chemokine receptor 5 CCR5 density the HIV-reservoir or rejection of the transplanted kidney 15 HIV-infected kidney transplant recipients will be recruited and their immunosuppressant regimen will be changed to include an mTOR inhibitor such as Sirolimus unless they are already on one In addition Maraviroc will be added to their HIV regimen unless they are already on Maraviroc Blood will be taken to measure markers of the HIV reservoir their CCR5 density and expression and immune activation
Detailed Description:
The study will be a pilot prospective single-center open-label non-randomized non-controlled clinical trial 15 HIV-infected kidney transplant recipients will be enrolled in the study Recruitment will be conducted through the renal transplant and infectious diseases outpatient clinics at the University of Maryland
The study will include patients with stable glomerular filtration rates GFRs 25 with suppressed HIV with CD4 counts 200 These patients will be recruited from the University of Marylands transplant nephrology and infectious diseases clinics The transplant nephrology clinic is a multidisciplinary clinic that incorporates nephrologists pharmacists to aid in medication management and coordinators to assist the patients in coordination of care
All patients will be screened either at the Institute of Human Virology IHV Clinical Research Unit or in the transplant nephrology or infectious disease clinics At this visit all patients will sign an informed consent as approved by our institutional review board IRB have a history and physical examination and have screening clinical and research labs drawn Additional requirements will be Trofile testing prior to enrollment Eligibility will be determined based upon these results
Study drugs will be prescribed if the patient is not already taking them starting on day 0 after an interval history and physical examination is performed and safety labs and pregnancy tests for women of childbearing potential are checked The medications will be filled by the patients pharmacy using their insurance as these are both Food and Drug Administration FDA approved drugs
Patients will be initially monitored weekly for sirolimus levels and renal function until their sirolimus is at the pre-determined by their transplant nephrologist steady state They will then be followed at week 4 and then every 12 weeks while they are on the new medication combination Safety labs blood counts renal and liver function HIV viral loads cluster of differentiation 4 CD4 counts and rapamycin levels will be reviewed at each of these visits and if not checked within the specified time period these labs will be repeated at the study visit Patients will also be advised about study adherence and monitored for adverse events
Safety and adverse event monitoring will occur each study visit Research nurses will inquire about adverse events that may or may not be related to study drugs Any unfavorable medical occurrences will be recorded whether or not considered related to the patients participation in the research or temporally associated with the patients participation in the research Any grade 3 or 4 AEs and all serious adverse events SAEs will be reviewed as they occur by the study team Adverse events AEs classified as grade 3 or higher occurring at a frequency greater than that expected by the study team will be reported to the IRB and principal investigator
The end of treatment visit will occur at week 96 Clinical safety labs blood counts renal and liver function HIV viral load CD4 counts and rapamycin levels will be performed at this visit if not done in the pre-specified time period Patients will be given the option in conjunction with their transplant nephrologist and their infectious disease provider to discontinue or continue the new medications at this time
The study will include patients with stable glomerular filtration rates GFRs 25 with suppressed HIV with CD4 counts 200 These patients will be recruited from the University of Marylands transplant nephrology and infectious diseases clinics The transplant nephrology clinic is a multidisciplinary clinic that incorporates nephrologists pharmacists to aid in medication management and coordinators to assist the patients in coordination of care
All patients will be screened either at the Institute of Human Virology IHV Clinical Research Unit or in the transplant nephrology or infectious disease clinics At this visit all patients will sign an informed consent as approved by our institutional review board IRB have a history and physical examination and have screening clinical and research labs drawn Additional requirements will be Trofile testing prior to enrollment Eligibility will be determined based upon these results
Study drugs will be prescribed if the patient is not already taking them starting on day 0 after an interval history and physical examination is performed and safety labs and pregnancy tests for women of childbearing potential are checked The medications will be filled by the patients pharmacy using their insurance as these are both Food and Drug Administration FDA approved drugs
Patients will be initially monitored weekly for sirolimus levels and renal function until their sirolimus is at the pre-determined by their transplant nephrologist steady state They will then be followed at week 4 and then every 12 weeks while they are on the new medication combination Safety labs blood counts renal and liver function HIV viral loads cluster of differentiation 4 CD4 counts and rapamycin levels will be reviewed at each of these visits and if not checked within the specified time period these labs will be repeated at the study visit Patients will also be advised about study adherence and monitored for adverse events
Safety and adverse event monitoring will occur each study visit Research nurses will inquire about adverse events that may or may not be related to study drugs Any unfavorable medical occurrences will be recorded whether or not considered related to the patients participation in the research or temporally associated with the patients participation in the research Any grade 3 or 4 AEs and all serious adverse events SAEs will be reviewed as they occur by the study team Adverse events AEs classified as grade 3 or higher occurring at a frequency greater than that expected by the study team will be reported to the IRB and principal investigator
The end of treatment visit will occur at week 96 Clinical safety labs blood counts renal and liver function HIV viral load CD4 counts and rapamycin levels will be performed at this visit if not done in the pre-specified time period Patients will be given the option in conjunction with their transplant nephrologist and their infectious disease provider to discontinue or continue the new medications at this time
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?:
False
Is an FDA AA801 Violation?:
None