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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02140944

Enrollment

Registered

2014-05-16

Start date

2015-02-05

Completion date

2022-10-19

Last updated

2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Cord blood transplantation, CCR5Δ32, HIV cure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Survival	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
Graft versus host disease	Through 5 years post-transplant	Graft versus host disease
Engraftment	Through 5 years post-transplant	Chimerism (≥ 98% of blood cells bearing CCR5∆32) and time to hematopoietic cell and immune recovery
HIV DNA level	Through 5 years post-transplant	HIV-1 proviral DNA levels in peripheral blood

Countries

United States

Outcome results