IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence
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ClinicalTrials.gov Identifier: NCT02140944 |
Recruitment Status :
Recruiting
First Posted : May 16, 2014
Last Update Posted : July 4, 2019
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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 | |||||
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First Submitted Date | May 14, 2014 | ||||
First Posted Date | May 16, 2014 | ||||
Last Update Posted Date | July 4, 2019 | ||||
Study Start Date | February 2015 | ||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | Complete list of historical versions of study NCT02140944 on ClinicalTrials.gov Archive Site | ||||
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 |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: For consenting participants, blood and tissue samples
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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 |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
25 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 2023 | ||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: • Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant. |
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Sex/Gender |
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Ages | 12 Months and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 ) |
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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 |
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Investigators |
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PRS Account | International Maternal Pediatric Adolescent AIDS Clinical Trials Group | ||||
Verification Date | July 2019 |