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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140944
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : March 1, 2023
Sponsor:
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 March 1, 2023
Actual Study Start Date February 5, 2015
Actual Primary Completion Date September 30, 2021   (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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2020)		 2
Original Estimated Enrollment
 (submitted: May 14, 2014)		 25
Actual Study Completion Date October 19, 2022
Actual Primary Completion Date September 30, 2021   (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
Removed Location Countries  
 
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
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access Criteria:

With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.

For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.

By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Current Responsible Party International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Original Responsible Party Same as current
Current Study Sponsor International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Original Study Sponsor Same as current
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 February 2023