Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02923076
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2016-09-28
Brief Title:
HIV Eradication Through Cord-blood Transplantation
Sponsor:
Puerta de Hierro University Hospital
Organization:
Puerta de Hierro University Hospital
Study Overview
Official Title:
A Prospective Clinical Research Protocol of Allogeneic CCR5 delta32delta32 Cord Blood Cell Transplantation to Cure HIV Infection
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
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:
HIVECT
Brief Summary:
Allogeneic hematopoietic cell transplantation from a CCR5 Δ32Δ32 unrelated donor performed for the first time in the Berlin patient provides the only evidence to date of long-term control of HIV infection Stringent criteria to select human leukocyte antigen HLA-matched conventional donors and low prevalence of the CCR5 Δ32Δ32 homozygous genotype 1 made the pursuit of patient number 2 unsuccessful for many years Cord blood CB transplantation allows more permissive HLA-matching criteria making the search for HLA-compatible Δ32Δ32 CB units potentially feasible for transplantation of HIV-infected individuals
The investigator team involved in this trial has recently reported the first such case of CCR5 delta32delta32 CB transplantation in a patient with HIV infection showing a reduction of the patients latent viral reservoir and upon achievement of full CB chimerism resistance of his CD4 T-lymphocytes to infection by HIV This proof of concept led the Spanish National Transplant Organization ONT to generate an inventory of over 150 CCR5 Δ32Δ32 CB units readily available for transplant
From this initial evidence and repository of CB units financial support from the Fundación Mutua Madrileña FMM has allowed the investigators to launch this first pilot clinical trial in this indication The study was launched in January 2016 at Hospital Universitario Puerta de Hierro Majadahonda All HIV virology and reservoir analyses are carried out by the AIDS Immunopathology Unit at the Spanish Instituto de Salud Carlos III Three additional transplant centres in Spain will also shortly open the trial
The investigator team involved in this trial has recently reported the first such case of CCR5 delta32delta32 CB transplantation in a patient with HIV infection showing a reduction of the patients latent viral reservoir and upon achievement of full CB chimerism resistance of his CD4 T-lymphocytes to infection by HIV This proof of concept led the Spanish National Transplant Organization ONT to generate an inventory of over 150 CCR5 Δ32Δ32 CB units readily available for transplant
From this initial evidence and repository of CB units financial support from the Fundación Mutua Madrileña FMM has allowed the investigators to launch this first pilot clinical trial in this indication The study was launched in January 2016 at Hospital Universitario Puerta de Hierro Majadahonda All HIV virology and reservoir analyses are carried out by the AIDS Immunopathology Unit at the Spanish Instituto de Salud Carlos III Three additional transplant centres in Spain will also shortly open the trial
Detailed Description:
None
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