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NCT02140944 Clinical Trial

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

HIV Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02140944
Other study ID # IMPAACT P1107
Secondary ID UM1AI068632UM1AI
Status Completed
Phase
First received
Last updated
Start date February 5, 2015
Est. completion date October 19, 2022

Study information
Verified date February 2023
Source International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date October 19, 2022
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Months and older
Eligibility 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) CCR5?32 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 CCR5?32 homozygous cord blood or bone marrow transplant within the last two years. Exclusion Criteria: • Received, or planning to receive, more than one CCR5?32 homozygous cord blood or bone marrow transplant.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Weill Cornell Uptown Clinical Research Site (7803) New York New York

Sponsors (3)
Lead Sponsor Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

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