Evidence map›Paper›PMID 29190337›Full record

ReviewClinical infectious diseases : an official publication of the Infectious Diseases Society of America2017

Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations.

Martina Penazzato, Devasena Gnanashanmugam, Pablo Rojo, Marc Lallemant, Linda L Lewis, Francesca Rocchi, Agnes Saint Raymond, Nathan Ford, Rohan Hazra, Carlo Giaquinto and 4 more

Erratum issuedAbstract readReview
In one paragraph

Review in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–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

21 citing papers in PubMed.

  1. Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Potential of Long-Acting Products to Transform the Treatment and Prevention of Human Immunodeficiency Virus (HIV) in Infants, Children, and Adolescents.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Antiretroviral Therapy in Children and Adolescents: A Look Into Modern Single Tablet Regimens.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Article
  12. Article
  13. HIV and antiretroviral therapy-related fat alterations.Nature reviews. Disease primers · 2020
    Review
  14. Article
  15. Review
  16. Review
  17. Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
  18. Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Martina PenazzatoHIV Department, World Health Organization, Geneva, Switzerland.
Devasena GnanashanmugamDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Pablo RojoHospital 12 de Octubre, Facultad de Medicina, Universidad Complutense, Madrid, Spain.
Marc LallemantDrugs for Neglected Diseases Initiative, Geneva, Switzerland.
Linda L LewisClinton Health Access Initiative, Bethesda, Maryland.
Francesca RocchiPaediatric European Network for Treatment of AIDS, Padua, Italy.
Agnes Saint RaymondEuropean Medicines Agency, London, United Kingdom.
Nathan FordHIV Department, World Health Organization, Geneva, Switzerland.
Rohan HazraEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Carlo GiaquintoDepartment of Women and Child Health, University of Padua, Italy.
Yodit BelewCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Diana M GibbMedical Research Council Clinical Trials Unit, University College London, United Kingdom.
Elaine J AbramsICAP, Mailman School of Public Health.
Paediatric Antiretroviral Working Group (PAWG)

Funding

Medical Research Council MC_UU_12023/29World Health Organization 001
6 · The paper itself

Abstract

Globally 1.8 million children are living with human immunodeficiency virus (HIV), yet only 51% of those eligible actually start treatment. Research and development (R&D) for pediatric antiretrovirals (ARVs) is a lengthy process and lags considerably behind drug development in adults. Providing safe, effective, and well-tolerated drugs for children remains critical to ensuring scale-up globally. We review current approaches to R&D for pediatric ARVs and suggest innovations to enable simplified, faster, and more comprehensive strategies to develop optimal formulations. Several approaches could be adopted, including focusing on a limited number of prioritized formulations and strengthening existing partnerships to ensure that pediatric investigation plans are developed early in the drug development process. Simplified and more efficient mechanisms to undertake R&D need to be put in place, and financing mechanisms must be made more sustainable. Lessons learned from HIV should be shared to support progress in developing pediatric formulations for other diseases, including tuberculosis and viral hepatitis.

Indexed as

Anti-HIV AgentsAnti-Retroviral AgentsChildDrug ApprovalDrug CombinationsDrug CompoundingHIV InfectionsHumansResearch Support as TopicAnti-HIV AgentsAnti-Retroviral AgentsDrug CombinationsantiretroviralschildrenformulationsHIVresearch

Identifiers

PMID29190337
PMCPMC5927327

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.