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IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence

This study is currently recruiting participants.
Verified July 2017 by International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT02140944
First Posted: May 16, 2014
Last Update Posted: July 13, 2017
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:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
  Purpose
IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older, who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer, hematopoietic disease, or other underlying disease.

Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: IMPAACT P1107: Cord Blood Transplantation With CCR5Δ32 Donor Cells in HIV-1 Infected Subjects Who Require Bone Marrow Transplantation for Any Indication and Its Observed Effects on HIV-1 Persistence

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Survival [ Time Frame: Through 5 years post-transplant ]
    Survival and event-free survival at 100 days, Week 26, Week 52, and then every six months until five years post-transplant

  • Graft versus host disease [ Time Frame: Through 5 years post-transplant ]
    Graft versus host disease

  • Engraftment [ Time Frame: Through 5 years post-transplant ]
    Chimerism (≥ 98% of blood cells bearing CCR5∆32) and time to hematopoietic cell and immune recovery

  • HIV DNA level [ Time Frame: Through 5 years post-transplant ]
    HIV-1 proviral DNA levels in peripheral blood


Biospecimen Retention:   Samples With DNA
For consenting participants, blood and tissue samples

Estimated Enrollment: 25
Study Start Date: February 2015
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre-Transplant Cohort
HIV-1 infected participants, enrolled prior to transplant, who receive a heterozygous or homozygous CCR∆32 cord blood transplant
Post-Transplant Cohort
HIV-1 infected participants, enrolled within 2 years after transplant, who receive a homozygous CCR∆32 cord blood transplant

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1 infected children and adults who undergo cord blood stem cell transplantation for treatment of cancer, hematopoietic disease, or other underlying disease
Criteria

Inclusion Criteria:

  • Confirmed HIV-1 infection
  • 12 months of age or older
  • Willing to provide written informed consent
  • Pre-Transplant Cohort: Underlying disease appropriate for stem cell transplant, as determined by the transplant team as part of standard of care.
  • Pre-Transplant Cohort: Availability of an appropriately matched (as determined by the transplant center) CCR5Δ32 cord blood unit (homozygous or heterozygous) and intention to proceed with transplantation. NOTE: Double cord transplants are allowed. If a double cord is used, at least one cord blood unit should be CCR5∆32 (homozygous or heterozygous).
  • Pre-Transplant Cohort: Received a CCR5Δ32 homozygous cord blood or bone marrow transplant within the last two years.

Exclusion Criteria:

• Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant.

  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): NCT02140944


Contacts
Contact: Anne Coletti, MS 919-544-7040 ext 11238 acoletti@fhi360.org

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States
Principal Investigator: Rachel Presti, MD, PhD         
United States, New York
Weill Cornell Uptown Clinical Research Site (7803) Recruiting
New York, New York, United States
Contact: Marshall Glesby, MD, PhD    212-746-7134    mag2005@med.cornell.edu   
Contact: Valery Hughes    212-746-4393    Vah9001@med.cornell.edu   
Principal Investigator: Koen van Besien, MD         
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: Yvonne Bryson, MD University of California, Los Angeles
  More Information

Additional Information:
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02140944     History of Changes
Other Study ID Numbers: IMPAACT P1107
UM1AI068632 ( U.S. NIH Grant/Contract )
UM1AI068616 ( U.S. NIH Grant/Contract )
UM1AI106716 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2014
First Posted: May 16, 2014
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Cord blood transplantation
CCR5Δ32
HIV cure

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases