Evidence map›Paper›PMID 28419200›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2017

Switching to Efavirenz Versus Remaining on Ritonavir-boosted Lopinavir in Human Immunodeficiency Virus-infected Children Exposed to Nevirapine: Long-term Outcomes of a Randomized Trial.

Pamela M Murnane, Renate Strehlau, Stephanie Shiau, Faeezah Patel, Ndileke Mbete, Gillian Hunt, Elaine J Abrams, Ashraf Coovadia, Louise Kuhn

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01146873 (Treatment Options for Protease Inhibitor-exposed Children), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT01146873 phase3completednot on this map

Treatment Options for Protease Inhibitor-exposed Children

TypeinterventionalSponsorColumbia UniversityRan2010 to 2014Enrolled300ConditionsHIV/AIDS, HIV InfectionsArmsEfavirenz (EFV), Lopinavir/ritonavir (LPV/r), Stavudine (D4T), Abacavir (ABC)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  14. Biomarkers of Aging in HIV-Infected Children on Suppressive Antiretroviral Therapy.Journal of acquired immune deficiency syndromes (1999) · 2018
    Observational
  15. Reply to Van de Wijer et al.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Pamela M MurnaneGertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.
Renate StrehlauEmpilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Stephanie ShiauGertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.
Faeezah PatelEmpilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Ndileke MbeteEmpilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Gillian HuntCentre for HIV and STIs, National Institute for Communicable Diseases, Johannesburg, South Africa.
Elaine J AbramsEmpilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Ashraf CoovadiaEmpilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Louise KuhnGertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.
University of the Witwatersrand · ZAColumbia University · USNational Institute for Communicable Diseases

Funding

TRAINEESHIPS IN AIDS PREVENTION STUDIEST32MH019105 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Carol Suzanne Camlin, Glenn-Milo Santos · 1989 to 2026
$15.3M
Host epigenetic and mitochondrial function in HIV-infected childrenR01HD073952 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI KUHN, LOUISE · 2012 to 2016
$3.7M
Treatment Options for Protease Inhibitor Exposed ChildrenR01HD061255 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI KUHN, LOUISE · 2010 to 2014
$2.9M
NICHD NIH HHS R01 HD061255NICHD NIH HHS R01 HD073952NIMH NIH HHS T32 MH019105
6 · The paper itself

Abstract

backgroundWe previously demonstrated the noninferiority of switching to efavirenz (EFV) versus remaining on ritonavir-boosted lopinavir (LPV/r) for virologic control in children infected with human immunodeficiency virus (HIV) and exposed to nevirapine (NVP) for prevention of mother-to-child transmission. Here we assess outcomes up to 4 years post-randomization.

methodsFrom 2010-2013, 298 NVP-exposed HIV-infected children ≥3 years of age were randomized to switch to EFV or remain on LPV/r in Johannesburg, South Africa (Clinicaltrials.gov NCT01146873). After trial completion, participants were invited to enroll into observational follow-up. We compared HIV RNA levels, CD4 counts and percentages, lipids, and growth across groups through four years post-randomization.

resultsHIV RNA levels 51-1000 copies/mL were less frequently observed in the EFV group than the LPV/r group (odds ratio [OR] 0.67, 95% confidence interval [CI]: 0.51-0.88, P = .004), as was HIV RNA >1000 copies/mL (OR 0.52 95% CI: 0.28-0.98, P = .04). The probability of confirmed HIV RNA >1000 copies/mL by 48 months was 0.07 and 0.12 in the EFV and LPV/r groups, respectively (P = .21). Children randomized to EFV had a reduced risk of elevated total cholesterol (OR 0.45 95% CI: 0.27-0.75, P = .002) and a reduced risk of abnormal triglycerides (OR 0.42, 95% CI 0.29-0.62, P < .001).

conclusionsOur results indicate that the benefits of switching virologically suppressed NVP-exposed HIV-infected children ≥3 years of age from LPV/r to EFV are sustained long-term. This approach has several advantages, including improved palatability, reduced metabolic toxicity, simplified cotreatment for tuberculosis, and preservation of second line options. CLINICAL TRIALS REGISTRATION: NCT01146873.

Indexed as

HIV InfectionsAlkynesAnti-HIV AgentsBenzoxazinesCD4 Lymphocyte CountChild, PreschoolCyclopropanesFemaleHIV-1HumansInfantLipidsLopinavirMaleNevirapineRitonavirAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenzLipidsLopinavirNevirapineRitonavirRNA, Viralantiretroviral therapyefavirenzHIV infectionslopinavir-ritonavirpediatrics

Identifiers

PMID28419200
PMCPMC5849095
OpenAlexW2606094994

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.