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

• ClinicalTrials.gov Identifier: NCT02140944
• Recruitment Status: Active, not recruiting
• First Posted: May 16, 2014
• Last Update Posted: October 19, 2020
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Tracking Information

• First Submitted Date: May 14, 2014
• First Posted Date: May 16, 2014
• Last Update Posted Date: October 19, 2020
• Study Start Date: February 2015
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2014)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

For consenting participants, blood and tissue samples

• Sampling Method: Non-Probability Sample
• Study Population: HIV-1 infected children and adults who undergo cord blood stem cell transplantation for treatment of cancer, hematopoietic disease, or other underlying disease
• Condition: HIV Infection
• Intervention: Not Provided

Study Groups/Cohorts

• Pre-Transplant Cohort
  HIV-1 infected participants, enrolled prior to transplant, who receive a heterozygous or homozygous CCR∆32 cord blood transplant
• Post-Transplant Cohort
  HIV-1 infected participants, enrolled within 2 years after transplant, who receive a homozygous CCR∆32 cord blood transplant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 13, 2020): 2
• Original Estimated Enrollment (submitted: May 14, 2014): 25
• Estimated Study Completion Date: March 2023
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02140944
• Other Study ID Numbers: IMPAACT P1107; UM1AI068632 ( U.S. NIH Grant/Contract ); UM1AI068616 ( U.S. NIH Grant/Contract ); UM1AI106716 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Study Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Collaborators

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

Investigators

• Study Chair: Yvonne Bryson, MD; University of California, Los Angeles

• PRS Account: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Verification Date: July 2020