Evidence map›Paper›PMID 25266426›Full record

Trial reportPediatrics2014

Using CD4 percentage and age to optimize pediatric antiretroviral therapy initiation.

Dwight E Yin, Meredith G Warshaw, William C Miller, Hannah Castro, Susan A Fiscus, Lynda M Harper, Linda J Harrison, Nigel J Klein, Joanna Lewis, Ann J Melvin and 3 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
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

13 authors.

Dwight E YinDivision of Infectious Diseases, Department of Pediatrics, Duke University Medical Center, Durham, North Carolina; Department of Epidemiology, Gillings School of Global Public Health, Division of Infectious Diseases, Department of Pediatrics, Children's Mercy Hospitals and Clinics, University of Missouri-Kansas City, Kansas City, Missouri; deyin@cmh.edu.
Meredith G WarshawCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts;
William C MillerDepartment of Epidemiology, Gillings School of Global Public Health, Division Infectious Diseases, Department of Medicine, School of Medicine, and.
Hannah CastroInfections Group, Medical Research Council Clinical Trials Unit.
Susan A FiscusDepartment of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina;
Lynda M HarperInfections Group, Medical Research Council Clinical Trials Unit.
Linda J HarrisonCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts;
Nigel J KleinInfectious Diseases and Microbiology Unit, Institute of Child Health, and.
Joanna LewisInstitute of Child Health and CoMPLEX, University College London, London, United Kingdom;
Ann J MelvinDivision of Pediatric Infectious Disease, Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, Washington; and.
Gareth Tudor-WilliamsSection of Pediatrics, Imperial College London, London, United Kingdom.
Ross E McKinneyDivision of Infectious Diseases, Department of Pediatrics, Duke University Medical Center, Durham, North Carolina;
PENPACT-1 (PENTA 9/PACTG 390) Study Team

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
Duke Research Training Program for PediatriciansT32HD043029 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2002 to 2017
$3.7M
Institutional Training Grant in Pediatric Infectious DiseaseT32HD060558 · NICHD · DUKE UNIVERSITY · PI CUNNINGHAM, COLEEN K. · 2011 to 2015
$1.0M
INTRACELLULAR PH PHYSIOLOGY IN MESANGIAL CELL GROWTHF32DK009001 · NIDDK · YALE UNIVERSITY · PI SINGH, SATISH K · 1993 to 1995
–
Medical Research Council G1001190Medical Research Council MC_U122886353NCATS NIH HHS UL1 TR002319NCRR NIH HHS UL1 RR025014NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS 5 U01 AI41110NIAID NIH HHS AI068632NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NICHD NIH HHS HHSN267200800001CNICHD NIH HHS T32 HD043029NICHD NIH HHS T32 HD060558NIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-9-001/HHSN267200800001C
6 · The paper itself

Abstract

backgroundQuantifying pediatric immunologic recovery by highly active antiretroviral therapy (HAART) initiation at different CD4 percentage (CD4%) and age thresholds may inform decisions about timing of treatment initiation.

methodsHIV-1-infected, HAART-naive children in Europe and the Americas were followed from 2002 through 2009 in PENPACT-1. Data from 162 vertically infected children, with at least World Health Organization "mild" immunosuppression and CD4% <10th percentile, were analyzed for improvement to a normal CD4% (≥10th percentile) within 4 years after HAART initiation. Data from 209 vertically infected children, regardless of immune status, were analyzed for CD4% outcomes at 4 years and viral failure within 4 years.

resultsSeventy-two percent of baseline immunosuppressed children recovered to normal within 4 years. Compared with "severe" immunosuppression, more children with "mild" immunosuppression (difference 36%, 95% confidence interval [CI]: 22% to 49%) or "advanced" immunosuppression (difference 20.8%, 95% CI: 5.8% to 35.9%) recovered a normal CD4%. For each 5-year increase in baseline age, the proportion of children achieving a normal CD4% declined by 19% (95% CI: 11% to 27%). Combining baseline CD4% and age effects resulted in >90% recovery when initiating HAART with "mild" immunosuppression at any age or "advanced" immunosuppression at age <3 years. Baseline CD4% effects became greater with increasing age (P = .02). At 4 years, most immunologic benefits were still significant but diminished. Viral failure was highest in infancy (56%) and adolescence (63%).

conclusionsInitiating HAART at higher CD4% and younger ages maximizes potential for immunologic recovery. Guidelines should weigh immunologic benefits against long-term risks.

Indexed as

AdolescentAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCD4 Lymphocyte CountCD4-Positive T-LymphocytesChildChild, PreschoolFemaleFollow-Up StudiesHIV-1HIV InfectionsHumansInfantInfant, NewbornMaleAnti-HIV AgentschildHIVimmunologicreconstitutiontreatment failure

Identifiers

PMID25266426
PMCPMC4179097

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.