Evidence map›Paper›PMID 27580060›Full record

Trial reportThe Pediatric infectious disease journal2016

Growth Recovery Among HIV-infected Children Randomized to Lopinavir/Ritonavir or NNRTI-based Antiretroviral Therapy.

Jane Achan, Abel Kakuru, Gloria Ikilezi, Florence Mwangwa, Albert Plenty, Edwin Charlebois, Sera Young, Diane Havlir, Moses Kamya, Theodore Ruel

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Pediatric infectious disease journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00978068 (A Randomized Open Label Trial of HIV Protease Inhibitors for the Prevention of Malaria in HIV-Infected Children), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 8% 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.

NCT00978068 phase3completednot on this map

A Randomized Open Label Trial of HIV Protease Inhibitors for the Prevention of Malaria in HIV-Infected Children

TypeinterventionalSponsorUniversity of California, San FranciscoRan2009 to 2013Enrolled176ConditionsMalaria, HIV InfectionsArmsLopinavir/Ritonavir (LPV/r), Nevirapine (NVP), Efavirenz (EFV), 2 nucleoside reverse transcriptase inhibitor (NRTI)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. 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

10 authors at 4 institutions in 3 countries.

Jane AchanFrom the *Medical Research Council Unit The Gambia; †Infectious Diseases Research Collaboration, Kampala, Uganda; ‡Department of Medicine, University of California, San Francisco, California; §Division of Nutritional Sciences, Cornell University, Ithaca, New York; ¶Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda; and ‖Department of Pediatrics, University of California, San Francisco, California.
Abel Kakuru
Gloria Ikilezi
Florence Mwangwa
Albert Plenty
Edwin Charlebois
Sera Young
Diane Havlir
Moses Kamya
Theodore Ruel
MRC Unit the Gambia · GMMakerere University · UGUniversity of California, San Francisco · USInfectious Diseases Research Collaboration · UG

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
The immunologic consequences of prenatal exposure to malariaP01HD059454 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2008 to 2017
$22.6M
HIV Disease Progression in African ChildrenK23HD060459 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI RUEL, THEODORE DUMONT · 2010 to 2014
$627k
NIAID NIH HHS UM1 AI069496NICHD NIH HHS K23 HD060459NICHD NIH HHS P01 HD059454NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundDiminished growth is highly prevalent among HIV-infected children and might be improved by antiretroviral therapy (ART). We examined growth recovery in a rural Ugandan cohort of HIV-infected children randomized to lopinavir/ritonavir (LPV/r) or non nucleoside reverse transcription inhibitor-based ART.

methodsHIV-infected children 2 months to 6 years of age were randomized to LPV/r- or non nucleoside reverse transcription inhibitor-based ART. Changes in weight-for-age (WAZ), height-for-age (HAZ) and weight-for-height Z-scores for 24 months were evaluated using generalized linear repeated measures models. Recovery from being underweight (WAZ<-2), stunted (HAZ<-2) and wasted (weight-for-height <-2) to Z-scores greater than -2 was also compared by arm using Kaplan-Meier survival and Cox proportional hazard modeling.

resultsA total of 129 children with median age of 3 years initiated therapy; 64 received LPV/r-based and 65 non nucleoside reverse transcription inhibitor-based ART (nevirapine: 36 and efavirenz: 29). The median (interquartile range) difference in growth measures between baseline and 24 months for LPV/r (n = 45) versus non nucleoside reverse transcription inhibitor-based therapy (n = 40) were as follows: WAZ, 0.47 (0.10, 1.62) versus 0.53 (0.03, 1.14) (P = 0.59) and HAZ, median 1.55 (0.78, 1.86) versus 1.19 (0.62, 1.65) (P = 0.23), respectively. ART regimen was not predictive of change in WAZ (β: -0.02, 95% confidence interval: -0.25, 0.20) or HAZ (β: 0.05, 95% confidence interval: -0.10, 0.19). The presence of confirmed virologic failure was not associated with growth.

conclusionsMost ART-naive children experienced recovery of both WAZ and HAZ over the 24 months after ART initiation, with no significant difference between those receiving LPV/r versus non nucleoside reverse transcriptase inhibitor-based ART. However, the persistence of median Z-scores below 0 underscores the need for additional strategies to improve growth outcomes in HIV+ African children.

Indexed as

Anti-Retroviral AgentsBody HeightBody WeightChild, PreschoolFemaleHIV InfectionsHumansInfantInfant, NewbornLopinavirMaleRitonavirAnti-Retroviral AgentsLopinavirRitonavir

Identifiers

PMID27580060
PMCPMC5106322
OpenAlexW2512520174

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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.