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

NCT02140944 | Completed

• 4 other identifiers: IMPAACT P1107UM1AI068632UM1AI068616UM1AI106716
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

Cord blood transplantation; CCR5Δ32; HIV cure

Outcome Measures

Primary Outcomes (4)

• Survival

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

  Through 5 years post-transplant

• Graft versus host disease

  Graft versus host disease

  Through 5 years post-transplant

• Engraftment

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

  Through 5 years post-transplant

• HIV DNA level

  HIV-1 proviral DNA levels in peripheral blood

  Through 5 years post-transplant

Study Arms (2)

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 Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Confirmed HIV-1 infection
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Weill Cornell Uptown Clinical Research Site (7803)

New York, New York, United States

Location

Related Publications (1)

• 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.

  PMID: 36931242 DERIVED

Related Links

• Study website

Biospecimen

Retention: SAMPLES WITH DNA

For consenting participants, blood and tissue samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Yvonne Bryson, MD

  University of California, Los Angeles

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: February 5, 2015
• Primary Completion: September 30, 2021
• Study Completion: October 19, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)