Evidence map›Paper›PMID 32649866›Full record

Trial reportThe lancet. HIV2020

Allogeneic bone marrow transplantation with post-transplant cyclophosphamide for patients with HIV and haematological malignancies: a feasibility study.

Christine M Durand, Adam A Capoferri, Andrew D Redd, Marianna Zahurak, Daniel I S Rosenbloom, Ayla Cash, Robin K Avery, Javier Bolaños-Meade, Catherine M Bollard, C Korin Bullen and 23 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. HIV, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01836068 (Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01836068 early_phase1completednot on this map

Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2013 to 2021Enrolled11ConditionsHIVArmsEnfuvirtide
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 47 citations in OpenAlex.

  1. Trial
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  4. Article
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  7. Management of Antiretroviral Therapy and Opportunistic Infections in People Living with HIV Undergoing Hematopoietic Stem Cell Transplant in British Columbia.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2024
    Article
  8. Article
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

33 authors at 8 institutions in 1 country.

Christine M DurandJohns Hopkins University School of Medicine, Baltimore, MD, USA; Sidney Kimmel Cancer Center, Baltimore, MD, USA. Electronic address: christinedurand@jhmi.edu.
Adam A CapoferriJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Andrew D ReddJohns Hopkins University School of Medicine, Baltimore, MD, USA; Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Marianna ZahurakSidney Kimmel Cancer Center, Baltimore, MD, USA.
Daniel I S RosenbloomDepartment of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co, Kenilworth, NJ, USA.
Ayla CashJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Robin K AveryJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Javier Bolaños-MeadeJohns Hopkins University School of Medicine, Baltimore, MD, USA; Sidney Kimmel Cancer Center, Baltimore, MD, USA.
Catherine M BollardSidney Kimmel Cancer Center, Baltimore, MD, USA; Program for Cell Enhancement and Technologies for Immunotherapy Children's National Health System, George Washington University Washington, DC, USA.
C Korin BullenJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Charles FlexnerJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Ephraim J FuchsSidney Kimmel Cancer Center, Baltimore, MD, USA.
Joel GallantJohns Hopkins University School of Medicine, Baltimore, MD, USA; Gilead Sciences, Foster City, CA, USA.
Doug E GladstoneSidney Kimmel Cancer Center, Baltimore, MD, USA.
Christopher D GockeSidney Kimmel Cancer Center, Baltimore, MD, USA.
Richard J JonesSidney Kimmel Cancer Center, Baltimore, MD, USA.
Yvette L KasamonSidney Kimmel Cancer Center, Baltimore, MD, USA.
Jun LaiJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Mark LevisSidney Kimmel Cancer Center, Baltimore, MD, USA.
Leo LuznikSidney Kimmel Cancer Center, Baltimore, MD, USA.
Kieren A MarrJohns Hopkins University School of Medicine, Baltimore, MD, USA; Sidney Kimmel Cancer Center, Baltimore, MD, USA.
Holly L McHughJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Seema Mehta SteinkeJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Paul PhamJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Christopher PohlmeyerJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Keith PratzSidney Kimmel Cancer Center, Baltimore, MD, USA.
Shmuel ShohamJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Nina Wagner-JohnstonSidney Kimmel Cancer Center, Baltimore, MD, USA.
Daniel XuJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Janet D SilicianoJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Thomas C QuinnJohns Hopkins University School of Medicine, Baltimore, MD, USA; Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Robert F SilicianoJohns Hopkins University School of Medicine, Baltimore, MD, USA; Howard Hughes Medical Institute, Baltimore, MD, USA.
Richard F AmbinderSidney Kimmel Cancer Center, Baltimore, MD, USA.
Johns Hopkins University · USSidney Kimmel Cancer Center · USJohns Hopkins Medicine · USGeorge Washington University · USGilead Sciences (United States) · USHoward Hughes Medical Institute · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USNational Institute of Allergy and Infectious Diseases · US

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
TUMOR VACCINESP01CA015396 · NCI · JOHNS HOPKINS UNIVERSITY · PI BORRELLO, IVAN M. · 1985 to 2016
$38.1M
International Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8M
Targeting MRDP01CA225618 · NCI · JOHNS HOPKINS UNIVERSITY · PI Catherine M. Bollard, KENNETH R COOKE · 2019 to 2026
$15.1M
Hodgkin Lymphoma in PLWH in South Africa: TB, EBV, and Tumor Molecular MarkersR01CA250069 · NCI · JOHNS HOPKINS UNIVERSITY · PI AMBINDER, RICHARD FREDERICK, XIAN, RENA · 2020 to 2024
$4.3M
Optimal Antiretroviral Therapy During Bone Marrow Transplant in HIV-1 InfectionK23CA177321 · NCI · JOHNS HOPKINS UNIVERSITY · PI DURAND, CHRISTINE MARIE · 2014 to 2018
$808k
NCI NIH HHS K23 CA177321NCI NIH HHS P01 CA015396NCI NIH HHS P01 CA225618NCI NIH HHS R01 CA250069NIAID NIH HHS P30 AI094189
6 · The paper itself

Abstract

backgroundAllogeneic blood or marrow transplantation (alloBMT) is a potentially life-saving treatment for individuals with HIV and haematological malignancies; challenges include identifying donors and maintaining antiretroviral therapy (ART). The objectives of our study were to investigate interventions to expand donor options and to prevent ART interruptions for patients with HIV in need of alloBMT.

methodsThis single-arm, interventional trial took place at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (Baltimore, MD, USA). Individuals with HIV who were at least 18 years of age and referred for alloBMT for a standard clinical indication were eligible. The only exclusion criterion was a history of documented resistance to enfuvirtide. We used post-transplant cyclophosphamide as graft-versus-host disease (GVHD) prophylaxis to expand donor options and an optimised ART strategy of avoiding pharmacoenhancers and adding subcutaneous enfuvirtide during post-transplant cyclophosphamide and during oral medication intolerance. Our primary outcome was the proportion of participants who maintained ART through day 60 after alloBMT. We measured the HIV latent reservoir using a quantitative viral outgrowth assay. This study is registered on ClinicalTrials.gov, NCT01836068.

findingsBetween June 1, 2013, and August 27, 2015, nine patients who were referred for transplant provided consent. Two patients had relapsed malignancy before donor searches were initiated. Seven patients had suitable donors identified (two matched sibling, two matched unrelated, two haploidentical, and one single-antigen mismatched unrelated) and proceeded to alloBMT. All patients maintained ART through day 60 and required ART changes (median 1, range 1-3) in the first 90 days. One patient stopped ART and developed HIV rebound with grade 4 meningoencephalitis at day 146. Among six patients who underwent alloBMT and had longitudinal measurements available, the HIV latent reservoir was not detected post-alloBMT in four patients with more than 95% donor chimerism, consistent with a 2·06-2·54 log

interpretationBy using post-transplant cyclophosphamide as GVHD prophylaxis, we successfully expanded alloBMT donor options for patients with HIV. Continuing ART with a regimen that includes enfuvirtide post-alloBMT was safe, but life-threatening viral rebound can occur with ART interruption.

fundingamfAR (the Foundation for AIDS Research), Johns Hopkins University Center for AIDS Research, and National Cancer Institute.

Indexed as

Bone Marrow TransplantationAdultAntiretroviral Therapy, Highly ActiveCombined Modality TherapyCyclophosphamideFeasibility StudiesFemaleGraft vs Host DiseaseHematologic NeoplasmsHIV InfectionsHumansMaleMiddle AgedTransplantation ConditioningTransplantation, HomologousTreatment OutcomeCyclophosphamide

Identifiers

PMID32649866
PMCPMC7484204
OpenAlexW3038386970

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.