HIV InfectionNCT02140944
IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence
An observational study of HIV Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- HIV Infection
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2015to 19 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Uptown Clinical Research Site (7803)
New York, New York
About this study
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
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.
- Conditions
- HIV Infection
- Keywords
- Cord blood transplantation, CCR5Δ32, HIV cure
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival and event-free survival at 100 days, Week 26, Week 52, and then every six months until five years post-transplant
Measured: Through 5 years post-transplant
Graft versus host disease
Graft versus host disease
Measured: Through 5 years post-transplant
Engraftment
Chimerism (≥ 98% of blood cells bearing CCR5∆32) and time to hematopoietic cell and immune recovery
Measured: Through 5 years post-transplant
HIV DNA level
HIV-1 proviral DNA levels in peripheral blood
Measured: Through 5 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study start5 Feb 2015
- Primary completion30 Sep 2021
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Yvonne Bryson, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140944
- Sponsor's protocol ID
- IMPAACT P1107
- Other IDs
- UM1AI068632, UM1AI068616, UM1AI106716
- Status last verified
- Feb 2023
- First submitted
- 14 May 2014
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Publications
Hsu J, Van Besien K, Glesby MJ, Pahwa S, Coletti A, Warshaw MG, Petz L, Moore TB, Chen YH, Pallikkuth S, Dhummakupt A, Cortado R, Golner A, Bone F, Baldo M, Riches M, Mellors JW, Tobin NH, Browning R, Persaud D, Bryson Y; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1107 Team. HIV-1 remission and possible cure in a woman after haplo-cord blood transplant. Cell. 2023 Mar 16;186(6):1115-1126.e8. doi: 10.1016/j.cell.2023.02.030.
PubMed 36931242
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02140944
- Acronym / sponsor ID
- IMPAACT P1107
- Conditions
- HIV Infection
- Keywords
- Cord blood transplantation, CCR5Δ32, HIV cure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 36931242Hsu J, Van Besien K, Glesby MJ, Pahwa S, Coletti A, Warshaw MG, Petz L, Moore TB, Chen YH, Pallikkuth S, Dhummakupt A, Cortado R, Golner A, Bone F, Baldo M, Riches M, Mellors JW, Tobin NH, Browning R, Persaud D, Bryson Y; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1107 Team. HIV-1 remission and possible cure in a woman after haplo-cord blood transplant. Cell. 2023 Mar 16;186(6):1115-1126.e8. doi: 10.1016/j.cell.2023.02.030.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Bryson, MD study chair
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Through 5 years post-transplant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.