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

See Contacts and Locations

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

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

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

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

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

Recruiting

Estimated Enrollment

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:

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

Contacts

Contact: Anne Coletti, MS

919-544-7040 ext 11238

acoletti@fhi360.org

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

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

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

July 2019

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