Evidence map›Paper›PMID 27128199›Full record

Trial reportAntiviral therapy2016

Acceptability of lopinavir/r pellets (minitabs), tablets and syrups in HIV-infected children.

Adeodata Kekitiinwa, Victor Musiime, Margaret J Thomason, Grace Mirembe, Marc Lallemant, Sarah Nakalanzi, David Baptiste, A Sarah Walker, Diana M Gibb, Ali Judd

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Antiviral therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Clinical Outcomes in Children With Human Immunodeficiency Virus Treated for Nonsevere Tuberculosis in the SHINE Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Observational
  12. Review
  13. Global sales of oral antibiotics formulated for children.Bulletin of the World Health Organization · 2020
    Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
  19. Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
  20. 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.

Adeodata KekitiinwaDepartment of Pediatrics and Adolescent Health, Baylor College of Medicine Children's Foundation Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital Kampala, Kampala, Uganda.
Victor MusiimeDepartment of Paediatrics, Joint Clinical Research Centre, Kampala, Uganda.
Margaret J ThomasonMedical Research Council Clinical Trials Unit, University College London, London, UK.
Grace MirembeDepartment of Paediatrics, Joint Clinical Research Centre, Kampala, Uganda.
Marc LallemantHCV and Paediatric HIV Program, Drugs for Neglected Diseases initiative, Geneva, Switzerland.
Sarah NakalanziDepartment of Pediatrics and Adolescent Health, Baylor College of Medicine Children's Foundation Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital Kampala, Kampala, Uganda.
David BaptisteMedical Research Council Clinical Trials Unit, University College London, London, UK.
A Sarah WalkerMedical Research Council Clinical Trials Unit, University College London, London, UK.
Diana M GibbMedical Research Council Clinical Trials Unit, University College London, London, UK.
Ali JuddMedical Research Council Clinical Trials Unit, University College London, London, UK.

Funding

Medical Research Council MC_UU_12023/17Medical Research Council MC_UU_12023/26Medical Research Council MC_UU_12023/29
6 · The paper itself

Abstract

backgroundLopinavir/ritonavir 'pellets' were recently tentatively approved for licensing. We describe their acceptability for infants and children up to 48 weeks.

methodsCHAPAS-2 was a randomized, two-period crossover trial comparing syrup and pellets in HIV-infected infants (n=19, group A, aged 3-<12 months) and children (n=26, group B, 1-<4 years) and tablets and pellets in older children (n=32, group C, 4-<13 years) from two clinics ('JCRC', 'PIDC') in Uganda. At week 8, all groups chose which formulation to continue. Acceptability data were collected at weeks 0, 4, 8, 12 and 48.

resultsFor groups A and B overall, the proportion preferring pellets increased between week 0 and week 12 and decreased at week 48 (group A 37%, 72%, 44%; group B 12%, 64% and 36%, respectively), although there were marked differences between clinics. For group C, pellets were progressively less preferred to tablets over time: 41%, 19% and 13% at weeks 0, 12 and 48, respectively. During follow-up unpleasant taste was similarly reported among young children taking pellets and syrups (37%/43% group A; 29%/26% group B), whereas among older children, pellets tasted worse than tablets (40%/2%). No participants reported problems with storage/transportation for pellets (0%/0%) unlike syrups (23%/13%).

conclusionsFor children <4 years, pellets were more acceptable at week 12 but not week 48. Clinic differences could reflect bias among health-care workers for different formulations. Pellets taste similar to syrup, are easier to store and transport than syrup and represent an alternative formulation for young children unable to swallow tablets; improvements in taste and support for health-care workers may help sustain acceptability.

Indexed as

Anti-HIV AgentsChildChild, PreschoolCross-Over StudiesHIV InfectionsHumansInfantLopinavirPatient Acceptance of Health CareTabletsTasteViral LoadAnti-HIV AgentsLopinavirTablets

Identifiers

PMID27128199
PMCPMC6029664

What OpenQuestion holds

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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.