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

NCT ID: NCT02140944

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-05

Study Completion Date

2022-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-Transplant Cohort

HIV-1 infected participants, enrolled prior to transplant, who receive a heterozygous or homozygous CCR∆32 cord blood transplant

No interventions assigned to this group

Post-Transplant Cohort

HIV-1 infected participants, enrolled within 2 years after transplant, who receive a homozygous CCR∆32 cord blood transplant

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yvonne Bryson, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

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Weill Cornell Uptown Clinical Research Site (7803)

New York, New York, United States

Site Status

Countries

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United States

References

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Hsu J, Van Besien K, Glesby MJ, Pahwa S, Coletti A, Warshaw MG, Petz L, Moore TB, Chen YH, Pallikkuth S, Dhummakupt A, Cortado R, Golner A, Bone F, Baldo M, Riches M, Mellors JW, Tobin NH, Browning R, Persaud D, Bryson Y; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1107 Team. HIV-1 remission and possible cure in a woman after haplo-cord blood transplant. Cell. 2023 Mar 16;186(6):1115-1126.e8. doi: 10.1016/j.cell.2023.02.030.

Reference Type DERIVED
PMID: 36931242 (View on PubMed)

Related Links

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Other Identifiers

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UM1AI068632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UM1AI068616

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UM1AI106716

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMPAACT P1107

Identifier Type: -

Identifier Source: org_study_id

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