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

International Maternal Pediatric Adolescent AIDS Clinical Trials Group2 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Infection

Eligibility

Sex: ALLMin age: 12 Months

Medical Language ↔ Plain English

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.

Locations (1)

Weill Cornell Uptown Clinical Research Site (7803)

New York, New York, United States

Outcomes

Primary Outcomes

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

Graft versus host disease

Time frame: Through 5 years post-transplant

Engraftment

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

Time frame: Through 5 years post-transplant

HIV DNA level

HIV-1 proviral DNA levels in peripheral blood

Time frame: Through 5 years post-transplant

Data from ClinicalTrials.gov

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