Evidence map›Paper›PMID 26193705›Full record

Observational studyAIDS (London, England)2015

Single-dose nevirapine exposure does not affect response to antiretroviral therapy in HIV-infected African children aged below 3 years.

Philippa Musoke, Alexander J Szubert, Victor Musiime, Kusum Nathoo, Patricia Nahirya-Ntege, Kuda Mutasa, David Eram Williams, Andrew J Prendergast, Moira Spyer, A Sarah Walker and 2 more

Open access · greenAbstract readObservational Study
In one paragraph

Observational study in AIDS (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 19% 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

8 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. The pharmacological treatment of acute HIV infections in neonates.Expert review of clinical pharmacology · 2017
    Review
  6. Observational
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 3 countries.

Philippa Musoke *Baylor-Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital, Kampala, Uganda; Makerere University College of Health Sciences, Kampala, Uganda.
Alexander J Szubert *MRC Clinical Trials Unit at University College London, London, UK.
Victor MusiimeJoint Clinical Research Centre, Kampala, Uganda; Makerere University College of Health Sciences, Kampala, Uganda.
Kusum NathooUniversity of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Patricia Nahirya-NtegeMedical Research Council/Uganda Virus Research Institute Uganda Research Unit on AIDS, Entebbe, Uganda.
Kuda MutasaZvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.
David Eram WilliamsJoint Clinical Research Centre, Kampala, Uganda.
Andrew J PrendergastQueen Mary University of London, London, UK.
Moira SpyerMRC Clinical Trials Unit at University College London, London, UK.
A Sarah WalkerMRC Clinical Trials Unit at University College London, London, UK.
Diana M GibbMRC Clinical Trials Unit at University College London, London, UK.
ARROW Trial Team
Joint Clinical Research Centre · UGMRC Clinical Trials Unit at UCL · GBUniversity College London · GBMulago Hospital · UGQueen Mary University of London · GBUganda Virus Research Institute · UGUniversity of Zimbabwe · ZWZvitambo Institute for Maternal and Child Health Research · ZW

Funding

Medical Research Council MC_EX_G0300400Medical Research Council MC_U122881852Medical Research Council MC_UU_12023/26Wellcome Trust 093768Wellcome Trust 093768/Z/10/ZWellcome Trust 100714
6 · The paper itself

Abstract

objectivesTo assess the impact of exposure to single-dose nevirapine (sdNVP) on virological response in young Ugandan/Zimbabwean children (<3 years) initiating antiretroviral therapy (ART), and to investigate other predictors of response.

designObservational analysis within the ARROW randomized trial.

methodssdNVP exposure was ascertained by the caregiver's self-report when the child initiated non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART. Viral load was assayed retrospectively over a median 4.1 years of follow-up. Multivariable logistic regression models were used to identify independent predictors of viral load below 80 copies/ml, 48 and 144 weeks after ART initiation (backwards elimination, exit P = 0.1).

resultsMedian (IQR) age at ART initiation was 17 (10-23) months in 78 sdNVP-exposed children vs. 21 (14-27) months in 289 non-exposed children (36 vs. 20% <12 months). At week 48, 49 of 73 (67%) sdNVP-exposed and 154 of 272 (57%) non-exposed children had viral load below 80 copies/ml [adjusted odds ratio (aOR) 2.34 (1.26-4.34), P = 0.007]; 79 and 77% had viral load below 400 copies/ml. Suppression was significantly lower in males (P = 0.009), those with higher pre-ART viral load (P = 0.001), taking syrups (P = 0.05) and with lower self-reported adherence (P = 0.04). At week 144, 55 of 73 (75%) exposed and 188 of 272 (69%) non-exposed children had less than 80 copies/ml [aOR 1.75 (0.93-3.29), P = 0.08]. There was no difference between children with and without previous sdNVP exposure in intermediate/high-level resistance to NRTIs (P > 0.3) or NNRTIs (P > 0.1) (n = 88) at week 144.

conclusionGiven the limited global availability of lopinavir/ritonavir, its significant formulation challenges in young children, and the significant paediatric treatment gap, tablet fixed-dose-combination NVP-based ART remains a good alternative to syrup lopinavir-based ART for children, particularly those over 1 year and even if exposed to sdNVP.

Indexed as

Viral LoadAnti-Retroviral AgentsChild, PreschoolFemaleHIV InfectionsHumansInfantMaleNevirapineRetrospective StudiesTreatment OutcomeUgandaZimbabweAnti-Retroviral AgentsNevirapine

Identifiers

PMID26193705
PMCPMC4833198
OpenAlexW2337736477

What OpenQuestion holds

Textmetadata
LicenceTDM
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.