Evidence map›Paper›PMID 27177316›Full record

Trial reportAIDS (London, England)2016

Treatment interruption after 2-year antiretroviral treatment initiated during acute/early HIV in infancy.

Dalton Wamalwa, Sarah Benki-Nugent, Agnes Langat, Kenneth Tapia, Evelyn Ngugi, Helen Moraa, Elizabeth Maleche-Obimbo, Vincent Otieno, Irene Inwani, Barbra A Richardson and 3 more

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

Trial report in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00428116 (Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
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.

NCT00428116 naterminatednot on this map

Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya (0-4.5 Month Randomized Controlled Trial)

TypeinterventionalSponsorUniversity of WashingtonRan2007 to 2014Enrolled140ConditionsHIV InfectionsArmsHAART
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 39 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 2 countries.

Dalton WamalwaaDepartment of Paediatrics, University of Nairobi, Nairobi, Kenya bDepartment of Global Health cBiostatistics, University of Washington, Seattle, Washington, USA dDepartment of Medical Microbiology, University of Nairobi, Nairobi, Kenya eDepartment of Human Biology, Fred Hutchinson Cancer Research Center fMedicine gPediatrics hEpidemiology, University of Washington, Seattle, Washington, USA.
Sarah Benki-Nugent
Agnes Langat
Kenneth Tapia
Evelyn Ngugi
Helen Moraa
Elizabeth Maleche-Obimbo
Vincent Otieno
Irene Inwani
Barbra A Richardson
Bhavna Chohan
Julie Overbaugh
Grace C John-Stewart
University of Washington · USUniversity of Nairobi · KEFred Hutch Cancer Center · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
Urgent Versus Post-Stabilization ART in HIV+ Children with Severe Co-infectionsR01HD023412 · NICHD · UNIVERSITY OF WASHINGTON · PI Grace C. John-Stewart, DALTON CHEKOKO WAMALWA · 1987 to 2026
$12.2M
Pediatric HIV-1 in Africa: Pathogenesis and ManagementK24HD054314 · NICHD · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C. · 2006 to 2016
$1.2M
Impact of HIV, immune activation, and ART on child neurodevelopment in KenyaK01NS080637 · NINDS · UNIVERSITY OF WASHINGTON · PI BENKI-NUGENT, SARAH F. · 2012 to 2016
$848k
NIAID NIH HHS P30 AI027757NICHD NIH HHS K24 HD054314NICHD NIH HHS R01 HD023412NINDS NIH HHS K01 NS080637
6 · The paper itself

Abstract

objectiveTreatment interruption has been well tolerated and durable in some pediatric studies but none have compared treatment interruption with continued antiretroviral treatment (ART) following ART initiation in early HIV. The objective of this study was to compare outcomes in treatment interruption versus continued ART among early-treated infants.

designRandomized trial (OPH-03; NCT00428116).

methodsThe trial included HIV-infected infants who initiated ART at less than 13 months of age, received ART for 24 months, and, if eligible (CD4% >25%, normal growth), were randomized to treatment interruption versus continued ART. Children in the treatment interruption group restarted ART if they met WHO ART-eligibility criteria. During 18-months postrandomization, primary outcomes were incidence of serious adverse events and growth. CD4%, viral load, morbidity, and growth were compared.

resultsOf 140 infants enrolled, 121 started ART, of whom 75 completed at least 24 months ART and 42 were randomized (21 per arm). ART was initiated at median age 5 months and randomization at 30 months. Among 21 treatment interruption children, 14 met ART restart criteria within 3 months. Randomization was discontinued by Data and Safety Monitoring Board due to low treatment interruption durability. At 18 months postrandomization, growth and serious adverse events were comparable between arms; hypercholesteremia incidence was higher in the continued arm (P = 0.03). CD4% and viral load did not differ between arms [CD4% 35% and median viral load undetectable (<150 copies/ml) in both arms, P = 0.9 for each comparison]. No infants had post-treatment viral control.

conclusionShort treatment interruption did not compromise 18-month CD4%, viral control, growth, or morbidity compared with continued ART among infants who started ART in early HIV infection.

Indexed as

Withholding TreatmentAnti-HIV AgentsCD4 Lymphocyte CountChild DevelopmentChild, PreschoolFemaleHIV InfectionsHumansInfantMaleTime FactorsTreatment OutcomeViral LoadAnti-HIV Agents

Identifiers

PMID27177316
PMCPMC5014697
OpenAlexW2515870255

What OpenQuestion holds

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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.