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HIV Eradication Through Cord-blood Transplantation (HIVECT)

This study is currently recruiting participants.
Verified October 2016 by Rafael F. Duarte, Puerta de Hierro University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02923076
First Posted: October 4, 2016
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Fundación Mutua Madrileña
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Rafael F. Duarte, Puerta de Hierro University Hospital
  Purpose

Allogeneic hematopoietic cell transplantation from a CCR5 Δ32/Δ32 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 Δ32/Δ32 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 Δ32/Δ32 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 delta32/delta32 CB transplantation in a patient with HIV infection, showing a reduction of the patient's 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 Δ32/Δ32 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.


Condition Intervention
HIV Other: CCR5 delta32/delta32 cord blood transplantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Research Protocol of Allogeneic CCR5 delta32/delta32 Cord Blood Cell Transplantation to Cure HIV Infection

Resource links provided by NLM:


Further study details as provided by Rafael F. Duarte, Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • HIV infection and viral reservoir - Cell-associated total HIV-1 DNA in CD4 T cells from peripheral blood and from gut-associated lymphoid tissue (GALT): Expressed in copies per million cells. [ Time Frame: Between 6-12 months: following discontinuation of antiretroviral therapy upon full CCR5 delta32/delta32 cord blood chimerism ]
  • HIV infection and viral reservoir - Viral copies in plasma and culture supernatants by Single Copy Assay and COBAS AMPLICOR HIV-1 Monitor v.1.5: Expressed in copies per mL. [ Time Frame: Between 6-12 months: following discontinuation of antiretroviral therapy upon full CCR5 delta32/delta32 cord blood chimerism ]
  • Ex vivo HIV-1 infection tests on CCR5 d32/d32-derived recipients CD4 T cells - Using patient's primary isolates and laboratory strains of HIV-1 with CCR5 and CXCR4 tropism: Expressed in ng/mL of p24 ELISA. [ Time Frame: Between 6-12 months: following discontinuation of antiretroviral therapy upon full CCR5 delta32/delta32 cord blood chimerism ]

Estimated Enrollment: 5
Study Start Date: June 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study treatment
Allogeneic transplantation with CCR5 delta32/delta32 hematopoietic cells from cord blood.
Other: CCR5 delta32/delta32 cord blood transplantation

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inform consent, that will be previously approved by the board, is required in order to carry out any procedure related to the study.
  • HIV infection.
  • Hematologic malignancies or any other condition with a standard indication for allogeneic hematopoietic cell transplantation. See indications by the European Society for Blood and Marrow Transplantation (EBMT). [Sureda A. et al. Indications for allo- and auto-SCT for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2015. Bone Marrow Transplantation (2015) 50, 1037-1056.]
  • Lack of HLA-identical related donor
  • Availability of at least one cord blood unit CCR5 delta32 homozygous that meets quality standards.

Exclusion Criteria:

  • Availability of HLA-identical related donor
  • Contraindication for allogeneic stem cell transplantation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923076


Contacts
Contact: María Esther Martínez Muñoz 0034 911917809 mmartinezmunoz@salud.madrid.org
Contact: Isabel Salcedo 0034 911916481 isabel.salcedo@salud.madrid.org

Locations
Spain
Hospital Universitario Puerta de Hierro- Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28008
Contact: María Esther Martínez Muñoz    0034 911917809    mmartinezmunoz@salud.madrid.org   
Contact: Isabel Salcedo    0034 911916481    isabel.salcedo@salud.madrid.org   
Sponsors and Collaborators
Puerta de Hierro University Hospital
Fundación Mutua Madrileña
Instituto de Salud Carlos III
Investigators
Principal Investigator: Rafael Duarte Palomino Hospital Universitario Puerta de Hierro- Majadahonda
  More Information

Responsible Party: Rafael F. Duarte, Head of the Hematopietic Cell Transplantation program, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT02923076     History of Changes
Other Study ID Numbers: HIVECT-1501
First Submitted: September 28, 2016
First Posted: October 4, 2016
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Rafael F. Duarte, Puerta de Hierro University Hospital:
Allogeneic Hematopoietic Cell Transplantation


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