Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582797
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Analytical Treatment Interruption in a Patient With HIV Post Allogeneic Stem Cell Transplantation From a CCR5 delta32 Homozygous Donor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analytical Treatment Interruption in a Patient With HIV Post Allogeneic Stem Cell Transplantation From a CCR5 delta32 Homozygous Donor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATI
Brief Summary:
Patients who have Human Immunodeficiency Virus-1 HIV-1 infection who also had a stem cell transplant may have achieved cure of their HIV infection Once the patients blood shows no detectable levels of HIV virus in their blood collected from a process called leukapheresis they will be closely monitored while discontinuing their HIV treatment which is know as antiretroviral therapy or ART They will be tested regularly and monitored for up to 52 weeks at which point they may be considered cured of their HIV
Detailed Description:
On week -1 a HIV VL and CD4 count will be drawn If VL remains undetectable at study week 0 and no other exclusion criteria noted subject will discontinue ART and enter ATI phase of the study HIV-1 plasma VL will be monitored every 2 weeks for 52 weeks then patient returns under the care of their HIV provider CD4 T cell count will be monitored every 4 weeks
Depressions symptom check with PHQ-9 check monthly with study visits Since patients might be cured and at risk of acquiring HIV during the period of treatment interruption they will be offered Prep on Demand Truvada to be used no more than once a month with notification of study PI when it happens When Prep on Demand is used we will ask patient to come in for ART drug level measurement same week
If patient meets any of the restart ART criteria during the interruption phase they will discontinue the ATI phase of study and re-start ART and enter the follow up ART phase If subject maintains undetectable plasma HIV VL assay quantification threshold 20 copiesmL they will remain off ART and continue to be monitored until restart criteria are met If patient meets the restart criteria they will be followed for 12 months post re-initiation of therapy by their HIV provider The first month post restart of therapy will require weekly visits followed by monthly visits thereafter until HIV VL is back 50 copiesmL Leukapheresis per previously approved protocol that patient consented to will be performed at 6 months and 12 months post ATI if in continued viral remission
Depressions symptom check with PHQ-9 check monthly with study visits Since patients might be cured and at risk of acquiring HIV during the period of treatment interruption they will be offered Prep on Demand Truvada to be used no more than once a month with notification of study PI when it happens When Prep on Demand is used we will ask patient to come in for ART drug level measurement same week
If patient meets any of the restart ART criteria during the interruption phase they will discontinue the ATI phase of study and re-start ART and enter the follow up ART phase If subject maintains undetectable plasma HIV VL assay quantification threshold 20 copiesmL they will remain off ART and continue to be monitored until restart criteria are met If patient meets the restart criteria they will be followed for 12 months post re-initiation of therapy by their HIV provider The first month post restart of therapy will require weekly visits followed by monthly visits thereafter until HIV VL is back 50 copiesmL Leukapheresis per previously approved protocol that patient consented to will be performed at 6 months and 12 months post ATI if in continued viral remission
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