Evidence map›Paper›PMID 33124144›Full record

ArticleHIV medicine2021

Long-term clinical, virological and immunological outcomes following planned treatment interruption in HIV-infected children.

R Freguja, A Bamford, M Zanchetta, P Del Bianco, C Giaquinto, L Harper, A Dalzini, T R Cressey, A Compagnucci, Y Saidi and 6 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in HIV medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 39% 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.

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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
  3. 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

16 authors at 6 institutions in 5 countries.

R FregujaSection of Oncology and Immunology, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
A BamfordDepartment of Paediatric Infectious Diseases, Great Ormond Street Hospital for Children NHS Trust, London, UK.ORCID 0000-0003-4764-229X
M ZanchettaImmunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy.
P Del BiancoClinical Trials and Biostatistic Unit, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy.
C GiaquintoDepartment of Mother and Child Health, University of Padova, Padova, Italy.
L HarperMRC Clinical Trials Unit, London, UK.
A DalziniSection of Oncology and Immunology, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
T R CresseyPHPT/IRD 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.
A CompagnucciINSERMSC10-US019, Essais thérapeutiques et maladies Infectieuses, Villejuif, France.
Y SaidiINSERMSC10-US019, Essais thérapeutiques et maladies Infectieuses, Villejuif, France.
Y RiaultINSERMSC10-US019, Essais thérapeutiques et maladies Infectieuses, Villejuif, France.
D FordMRC Clinical Trials Unit, London, UK.
D GibbMRC Clinical Trials Unit, London, UK.
N KleinDepartment of Paediatric Infectious Diseases, Great Ormond Street Hospital for Children NHS Trust, London, UK.
A De RossiSection of Oncology and Immunology, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
Paediatric European Network for Treatment of AIDS (PENTA) 11 Trial Team
University of Padua · ITInserm · FRMRC Clinical Trials Unit at UCL · GBGreat Ormond Street Hospital · GBIstituto Oncologico Veneto · ITHarvard University · US

Funding

Medical Research Council MC_UU_12023/26
6 · The paper itself

Abstract

objectivesPlanned treatment interruption (PTI) of antiretroviral therapy (ART) in adults is associated with adverse outcomes. The PENTA 11 trial randomized HIV-infected children to continuous ART (CT) vs. CD4-driven PTIs. We report 5 years' follow-up after the end of main trial.

methodsPost-trial, all children resumed ART. Clinical, immunological, virological and treatment data were collected annually. A sub-study investigated more detailed immunophenotype. CT and PTI arms were compared using intention-to-treat. Laboratory parameters were compared using linear regression, adjusting for baseline values; mixed models were used to include all data over time.

resultsIn all, 101 children (51 CT, 50 PTI) contributed a median of 7.6 years, including 5.1 years of post-trial follow-up. Post-trial, there were no deaths, one pulmonary tuberculosis and no other CDC stage B/C events. At 5 years post-trial, 90% of children in the CT vs. 82% in the PTI arm had HIV RNA < 50 copies/mL (P = 0.26). A persistent increase in CD8 cells was observed in the PTI arm. The sub-study (54 children) suggested that both naïve and memory populations contributed to higher CD8 cells following PTI. Mean CD4/CD8 ratios at 5 years post-trial were 1.22 and 1.08 in CT and PTI arms, respectively [difference (CT - PTI) = -0.15; 95% CI: -0.34-0.05), P = 0.14]. The sub-study also suggested that during the trial and at early timepoints after the end of the trial, reduction in CD4 in the PTI arm was mainly from loss of CD4 memory cells.

conclusionsChildren tolerated PTI with few long-term clinical, virological or immunological consequences.

Indexed as

HIV InfectionsCD4 Lymphocyte CountCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesChildHumansRandomized Controlled Trials as TopicTreatment OutcomeViral LoadARVchildrenHIVimmunologytreatment interruptionvirology

Identifiers

PMID33124144
PMCPMC8436743
OpenAlexW3097892958

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.