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CompletedNCT02140944Updated Mar 1, 2023

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

An observational study in HIV Infection, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Completed at 1 site in United States. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2
Ages
12 Months and older
Sex
All
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Study 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.

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Conditions studied

  • HIV Infection

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Keywords

  • Cord blood transplantation
  • CCR5Δ32
  • HIV cure
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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 2 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Months and older
Sexes eligible
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and 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

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What researchers measure

Primary outcomes

  1. Survival

    Survival and event-free survival at 100 days, Week 26, Week 52, and then every six months until five years post-transplant

    Time frame: Through 5 years post-transplant

  2. Graft versus host disease

    Graft versus host disease

    Time frame: Through 5 years post-transplant

  3. Engraftment

    Chimerism (≥ 98% of blood cells bearing CCR5∆32) and time to hematopoietic cell and immune recovery

    Time frame: Through 5 years post-transplant

  4. HIV DNA level

    HIV-1 proviral DNA levels in peripheral blood

    Time frame: Through 5 years post-transplant

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Study locations

1 site
  • Weill Cornell Uptown Clinical Research Site (7803)
    New York, New York, United States
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References and documents

Related links

Individual participant data

Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02140944
Lead sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
May 16, 2014
Start date
Feb 5, 2015
Primary completion
Sep 30, 2021
Completion
Oct 19, 2022
Last update
Mar 1, 2023

Study contacts

Yvonne Bryson, MD
study chair · University of California, Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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