Evidence map›Paper›PMID 19380868›Full record

Trial reportBlood2009

IL-7 administration drives T cell-cycle entry and expansion in HIV-1 infection.

Irini Sereti, Richard M Dunham, John Spritzler, Evgenia Aga, Michael A Proschan, Kathy Medvik, Catherine A Battaglia, Alan L Landay, Savita Pahwa, Margaret A Fischl and 11 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 205 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
205citing papers in PubMed, 2 pooled it
13.3field-weighted citation impact, top 1% 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.

NCT00099671 phase1completednot on this map

A Phase I, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety of Subcutaneous Single Dose Interleukin-7 in HIV-1-Infected Subjects Who Are Receiving Antiretroviral Treatment

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2005 to 2007Enrolled25ConditionsHIV InfectionsArmsRecombinant human interleukin-7
NCT01368107 phase2completednot on this mapstarted 2011, after this paper: background citation

A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

TypeinterventionalSponsorCentre Leon BerardRan2011 to 2014Enrolled24ConditionsMetastatic Breast CancerArmsplacebo, interleukin 7
3 · Its place in the literature

Who cites it

205 citing papers in PubMed, 2 syntheses or guidelines pooled it, 332 citations in OpenAlex.

  1. Pooled it
  2. The Hitchhiker Guide to CD4Frontiers in immunology · 2021
    Pooled it
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  7. Adjuvant Immunotherapy to Improve Outcome in High-Risk Pediatric Sarcomas.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Trial
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145 more citing papers are in PubMed but not listed here.

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

21 authors at 11 institutions in 1 country.

Irini SeretiNational Institute of Allergy and Infectious Diseases, Bethesda, MD 20892, USA. isereti@niaid.nih.gov
Richard M Dunham
John Spritzler
Evgenia Aga
Michael A Proschan
Kathy Medvik
Catherine A Battaglia
Alan L Landay
Savita Pahwa
Margaret A Fischl
David M Asmuth
Allan R Tenorio
John D Altman
Lawrence Fox
Susan Moir
Angela Malaspina
Michel Morre
Renaud Buffet
Guido Silvestri
Michael M Lederman
ACTG 5214 Study Team
National Institute of Allergy and Infectious Diseases · USCase Western Reserve University · USHarvard University · USRush University Medical Center · USUniversity of Miami · USAIDS Clinical Trials Group · USEmory University · USOffice of AIDS Research · USPhiladelphia University · USUniversity of California Davis Medical Center · USUniversity of Pennsylvania · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
Immunopathogenic Mechanisms of Human Immunodeficiency Virus (HIV) DiseaseZIAAI001121 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SERETI, IRINI · 2010 to 2025
$27.2M
Role of B Lymphocytes In HIV Infection And PathogenesisZIAAI000825 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MOIR, SUSAN · 2009 to 2025
$24.5M
WOMEN'S HEALTH AGENDAU01AI025915 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MURPHY, ROBERT L. · 1987 to 2006
$15.3M
WOMEN'S HEALTH AGENDAU01AI025879 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI LEDERMAN, MICHAEL MARCEL · 1987 to 2006
$14.0M
WOMEN'S HEALTH AGENDAU01AI027675 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI FISCHL, MARGARET A · 1988 to 2006
$10.5M
Intramural NIH HHSNIAID NIH HHS AI 25879NIAID NIH HHS AI 25915NIAID NIH HHS AI 27675NIAID NIH HHS AI 38855NIAID NIH HHS AI 38858NIAID NIH HHS AI 68636NIAID NIH HHS U01 AI025879NIAID NIH HHS U01 AI025915NIAID NIH HHS U01 AI027675NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI068636NIAID NIH HHS UM1 AI068636
6 · The paper itself

Abstract

Interleukin 7 (IL-7) is a common gamma chain receptor cytokine implicated in thymopoiesis and in peripheral expansion and survival of T lymphocytes. The safety and activity of recombinant human IL-7 (rhIL-7) administration were therefore examined in HIV-infected persons. In this prospective randomized placebo-controlled study, a single subcutaneous dose of rhIL-7 was well tolerated with biologic activity demonstrable at 3 microg/kg and a maximum tolerated dose of 30 microg/kg. Injection site reactions and transient elevations of liver function tests were the most notable side effects. Transient increases in plasma HIV-RNA levels were observed in 6 of 11 IL-7-treated patients. Recombinant hIL-7 induced CD4 and CD8 T cells to enter cell cycle; cell-cycle entry was also confirmed in antigen-specific CD8 T cells. Administration of rhIL-7 led to transient down-regulation of the IL-7 receptor alpha chain (CD127) in both CD4(+) and CD8(+) T cells. Single-dose rhIL-7 increased the numbers of circulating CD4(+) and CD8(+) T cells, predominantly of central memory phenotype. The frequency of CD4(+) T cells with a regulatory T-cell phenotype (CD25(high) CD127(low)) did not change after rhIL-7 administration. Thus, rhIL-7 has a biologic and toxicity profile suggesting a potential for therapeutic trials in HIV infection and other settings of lymphopenia. This clinical trial has been registered at http://www.clinicaltrials.gov under NCT0099671.

Indexed as

HIV-1AdultCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCell CycleChemical and Drug Induced Liver InjuryDown-RegulationFemaleHIV InfectionsHumansImmunologic MemoryInterleukin-7Interleukin-7 Receptor alpha SubunitLymphocyte CountMaleMaximum Tolerated DoseIL7 protein, humanInterleukin-7Interleukin-7 Receptor alpha SubunitRecombinant Proteins

Identifiers

PMID19380868
PMCPMC2710926
OpenAlexW2002051431

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.