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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140944
Recruitment Status : Active, not recruiting
First Posted : May 16, 2014
Last Update Posted : September 26, 2022
Sponsor:
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

Study Description
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Brief Summary:
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 or disease
HIV Infection

Study Design
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Study Type : Observational
Actual Enrollment : 2 participants
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
Actual Study Start Date : February 5, 2015
Actual Primary Completion Date : September 30, 2021
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

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

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

  4. 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

Eligibility Criteria
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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
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
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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


Locations
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United States, New York
Weill Cornell Uptown Clinical Research Site (7803)
New York, New York, United States
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
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Study Chair: Yvonne Bryson, MD University of California, Los Angeles
More Information
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Additional Information:

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Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02140944    
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 Posted: May 16, 2014    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access Criteria:

With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.

For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.

By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Cord blood transplantation
CCR5Δ32
HIV cure
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases