Evidence map›Paper›PMID 37815035›Full record

Trial reportJournal of the Pediatric Infectious Diseases Society2023

Efficacy, Safety, and Tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Results Through Week 96 from IMPAACT 2014.

Supattra Rungmaitree, Linda Aurpibul, Brookie M Best, Xiang Li, Meredith G Warshaw, Hong Wan, Nicole H Tobin, Patricia Jumes, Randi Leavitt, Katie McCarthy and 10 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the Pediatric Infectious Diseases Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

20 authors at 13 institutions in 3 countries.

Supattra RungmaitreeDepartment of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Linda AurpibulResearch Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.ORCID 0000-0003-0246-8187
Brookie M BestSkaggs School of Pharmacy and Pharmaceutical Sciences and Pediatrics Department, School of Medicine-Rady Children's Hospital San Diego, University of California San Diego, San Diego, California, USA.
Xiang LiFrontier Science Technology and Research Foundation, Madison, Wisconsin, USA.
Meredith G WarshawCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Hong WanMerck & Co., Inc., Rahway, New Jersey, USA.
Nicole H TobinDepartment of Pediatrics, Division of Pediatric Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
Patricia JumesMerck & Co., Inc., Rahway, New Jersey, USA.
Randi LeavittMerck & Co., Inc., Rahway, New Jersey, USA.
Katie McCarthyFHI 360, Durham, North Carolina, USA.
Rachel ScheckterFHI 360, Durham, North Carolina, USA.
Pradthana OunchanumChiangrai Prachanukroh Hospital PHPT, Chiang Rai, Thailand.
Avy ViolariPerinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Hedy TepplerMerck & Co., Inc., Rahway, New Jersey, USA.
Havilland CampbellMerck & Co., Inc., Rahway, New Jersey, USA.
Chelsea KrotjeFrontier Science, Amherst, New York, USA.
Ellen TownleyDAIDS/NIAID/NIH, Rockville, Maryland, USA.
Jack MoyeNICHD/NIH, Bethesda, Maryland, USA.
Ann J MelvinDepartment of Pediatrics, Division of Pediatric Infectious Disease, University of Washington and Seattle Children's Research Institute, Seattle, Washington, USA.
IMPAACT 2014 study team
Merck & Co., Inc., Rahway, NJ, USA (United States) · USFamily Health International 360 · USFrontier Science & Technology Research Foundation · USUniversity of the Witwatersrand · ZACancer Research And Biostatistics · USChiang Mai University · THChiangRai Prachanukroh Hospital · THEunice Kennedy Shriver National Institute of Child Health and Human Development · USNational Institutes of Health · USSeattle Children's Hospital · USSiriraj Hospital · THUniversity of California, Los Angeles · USUniversity of California San Diego · US

Funding

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
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001I
6 · The paper itself

Abstract

backgroundIMPAACT 2014 study is a phase I/II, multicenter, open-label, nonrandomized study of doravirine (DOR) co-formulated with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) as fixed-dose combination (DOR FDC) in adolescents with HIV-1. We report the efficacy, safety, and tolerability of DOR FDC through 96 weeks.

methodsParticipants were adolescents aged 12 to <18 years who weighed at least 45 kg and who were either antiretroviral (ARV)-naïve or virologically suppressed without documented resistance mutations to DOR/3TC/TDF. The efficacy endpoint was the proportion of participants with HIV-1 RNA <40 copies/mL assessed at weeks 48 and 96 using the observed failure approach. Safety and tolerability outcomes were incidence of adverse events (AEs) and treatment discontinuations.

resultsA total of 45 adolescents, median age 15 (range, 12-17) years, 58% females, were enrolled and 2 (4.4%) participants were ARV naïve. Of the 45 participants, 42 (93.3%) completed the study and 41 (91.1%) completed the study treatment. At week 48, 41/42 (97.6%; 95% confidence interval [CI], 87.4-99.9) and week 96, 37/40 (92.5%; 95% CI, 79.6-98.4) participants had achieved or maintained HIV-1 RNA <40 copies/mL. There were no treatment-related discontinuations due to AEs and no drug-related AEs ≥grade 3 or deaths.

conclusionsWe found once-daily dosing of DOR FDC to be safe and well tolerated for maintaining viral suppression through 96 weeks in adolescents living with HIV-1.

Indexed as

Anti-HIV AgentsHIV InfectionsHIV SeropositivityAdolescentAnti-Retroviral AgentsFemaleHumansLamivudineMalePyridonesRNATenofovirTreatment OutcomeTriazolesAnti-HIV AgentsAnti-Retroviral AgentsdoravirineLamivudinePyridonesRNATenofovirTriazolesadolescentsdoravirineHIV-1MK-1439A

Identifiers

PMID37815035
PMCPMC11494224
OpenAlexW4387472368

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.