Skip to main content
OpenTrials
Completed

NCT Number: NCT02140944

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Uptown Clinical Research Site (7803)

New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
May 16, 2014
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.