IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence
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ClinicalTrials.gov Identifier: NCT02140944 |
Recruitment Status :
Active, not recruiting
First Posted : May 16, 2014
Last Update Posted : September 26, 2022
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Condition or disease |
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HIV Infection |
Study Type : | Observational |
Actual Enrollment : | 2 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | February 5, 2015 |
Actual Primary Completion Date : | September 30, 2021 |
Estimated Study Completion Date : | November 30, 2022 |
Group/Cohort |
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Pre-Transplant Cohort
HIV-1 infected participants, enrolled prior to transplant, who receive a heterozygous or homozygous CCR∆32 cord blood transplant
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Post-Transplant Cohort
HIV-1 infected participants, enrolled within 2 years after transplant, who receive a homozygous CCR∆32 cord blood transplant
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- 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 12 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140944
United States, New York | |
Weill Cornell Uptown Clinical Research Site (7803) | |
New York, New York, United States |
Study Chair: | Yvonne Bryson, MD | University of California, Los Angeles |
Responsible Party: | International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
ClinicalTrials.gov Identifier: | 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 ) |
First Posted: | May 16, 2014 Key Record Dates |
Last Update Posted: | September 26, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (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 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. |
Cord blood transplantation CCR5Δ32 HIV cure |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |