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IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence
This study is currently recruiting participants.
Verified June 2016 by International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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
ClinicalTrials.gov Identifier:
NCT02140944
First received: May 14, 2014
Last updated: June 10, 2016
Last verified: June 2016
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Purpose
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.
| Condition |
|---|
| HIV Infection |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Primary Outcome Measures:
- 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
For consenting participants, blood and tissue samples
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2015 |
| Estimated Study Completion Date: | March 2023 |
| Estimated Primary Completion Date: | March 2023 (Final data collection date for primary outcome measure) |
| 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
|
Eligibility| Ages Eligible for Study: | 12 Months and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02140944
Please refer to this study by its ClinicalTrials.gov identifier: NCT02140944
Contacts
| Contact: Anne Coletti, MS | 919-544-7040 ext 11238 | acoletti@fhi360.org |
Locations
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St Louis, Missouri, United States | |
| Principal Investigator: Rachel Presti, MD, PhD | |
| United States, New York | |
| Weill Cornell Uptown Clinical Research Site (7803) | Recruiting |
| New York, New York, United States | |
| Contact: Marshall Glesby, MD, PhD 212-746-7134 mag2005@med.cornell.edu | |
| Contact: Valery Hughes 212-746-4393 Vah9001@med.cornell.edu | |
| Principal Investigator: Koen van Besien, MD | |
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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 |
More Information
Additional Information:
| Responsible Party: | International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT02140944 History of Changes |
| Other Study ID Numbers: |
IMPAACT P1107 UM1AI068632 ( US NIH Grant/Contract Award Number ) UM1AI068616 ( US NIH Grant/Contract Award Number ) UM1AI106716 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | May 14, 2014 |
| Last Updated: | June 10, 2016 |
Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
|
Cord blood transplantation CCR5Δ32 HIV cure |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on June 28, 2017