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

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT02140944

UM1AI068632 (U.S. NIH Grant/Contract)

IMPAACT P1107

UM1AI106716 (U.S. NIH Grant/Contract)

UM1AI068616 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

2 participants in 2 patient groups

Pre-Transplant Cohort

Description:

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

Post-Transplant Cohort

Description:

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