HIV Eradication Through Cord-blood Transplantation (HIVECT)

October 30, 2016 updated by: Rafael F. Duarte, Puerta de Hierro University Hospital

A Prospective Clinical Research Protocol of Allogeneic CCR5 delta32/delta32 Cord Blood Cell Transplantation to Cure HIV Infection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study treatment
Allogeneic transplantation with CCR5 delta32/delta32 hematopoietic cells from cord blood.
Other: CCR5 delta32/delta32 cord blood transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Between 6-12 months: following discontinuation of antiretroviral therapy upon full CCR5 delta32/delta32 cord blood chimerism

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Collaborators

Fundación Mutua Madrileña
Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Rafael Duarte Palomino, Hospital Universitario Puerta de Hierro- Majadahonda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

October 1, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 30, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HIVECT-1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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