Trial reportJournal of acquired immune deficiency syndromes (1999)2011
Pharmacokinetics of lopinavir/ritonavir crushed versus whole tablets in children.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
49 citing papers in PubMed, 1 synthesis or guideline pooled it, 100 citations in OpenAlex.
- Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products.The AAPS journal · 2021Pooled it
- Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial.Intensive care medicine · 2021Trial
- Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection.The Journal of antimicrobial chemotherapy · 2020Trial
- Acceptability of lopinavir/r pellets (minitabs), tablets and syrups in HIV-infected children.Antiviral therapy · 2016Trial
- Prevalence, associated factors and geospatial patterns of HIV drug resistance in South Africa among the virally unsuppressed adults: updated results from the 2017 national HIV household survey.BMC public health · 2026Article
- Drug Manipulation in Pediatric Care: A Scoping Review of a Widespread Practice Signaling Systemic Gaps in Pharmaceutical Provision.Pharmacy (Basel, Switzerland) · 2025Review
- The Impact of the Core-Shell Fiber Composition on the Properties and Stability of the Electrospun Films.Nanotechnology, science and applications · 2025Article
- 'Challenges in pediatric medicine access in Albania: insights from community Pharmacists'.Journal of pharmaceutical policy and practice · 2025Article
- Antiretroviral Therapy during Long-term Surgical Care: 'Exploring Difficult Cases in HIV Clinics' of the Korean Society for AIDS Conference in 2023.Infection & chemotherapy · 2024Review
- The interplay of poorly soluble drugs in dissolution from amorphous solid dispersions.International journal of pharmaceutics: X · 2024Article
- Article
- Evaluation of alignment of the reimbursement medicines list for children in Albania with the WHO essential medicines list for children.Journal of pharmaceutical policy and practice · 2024Article
- Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study.The AAPS journal · 2023Article
- Crushing lopinavir/ritonavir tablets does not result in lower exposure to lopinavir/ritonavir in adult patients with COVID-19.European journal of hospital pharmacy : science and practice · 2023Article
- Paediatric medicine issues and gaps from healthcare workers point of view: survey results and a narrative review from the global accelerator for paediatric formulations project.Frontiers in pharmacology · 2023Article
- How to use COVID-19 antiviral drugs in patients with chronic kidney disease.Frontiers in pharmacology · 2023Review
- Health system response to preventing mother-to-child transmission of HIV policy changes in Zambia: a health system dynamics analysis of primary health care facilities.Global health action · 2022Review
- Manipulated Oral and Rectal Drugs in a Paediatric Swedish University Hospital, a Registry-Based Study Comparing Two Study-Years, Ten Years Apart.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Drugs for neglected tropical diseases: availability of age-appropriate oral formulations for young children.Parasites & vectors · 2022Review
- Antivirals and the Potential Benefits of Orally Inhaled Drug Administration in COVID-19 Treatment.Journal of pharmaceutical sciences · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
objectiveLopinavir/ritonavir (Kaletra) is first-line therapy for pediatric HIV infection. In clinical practice, Kaletra tablets are occasionally crushed for pediatric administration. This study compared lopinavir/ritonavir exposure between whole and crushed tablets in HIV-infected children.
designThis was a randomized, open-label, cross-over study of pediatric patients taking lopinavir/ritonavir as part of their antiretroviral regimen. Each subject had 2 separate (within 30 days) steady-state 12-hour pharmacokinetic (PK) studies with crushed and whole 200/50 mg lopinavir/ritonavir tablets.
methodsPK blood samples were drawn at 0 (predose), 1, 2, 4, 6, 8, and 12 hours postdose. Lopinavir and ritonavir plasma concentrations measured by high-performance liquid chromatography were used to calculate non-compartmental area under the concentration versus time curve (AUC) and clearance. Wilcoxon signed-rank tests compared PK values between crushed and whole tablets.
resultsTwelve children, median age of 13 years (10-16 years), took 550/138 mg·m(-2) per day lopinavir/ritonavir divided every 12 hours. The median lopinavir AUC after crushed and whole tablets were 92 mg·hr·L(-1) and 144 mg·hr·L(-1), respectively, with an AUC ratio of 0.55 (P = 0.003). Median ritonavir AUC of crushed and whole tablets were 7 mg·hr·L(-1) and 13.3 mg·hr·L(-1), respectively, with an AUC ratio of 0.53 (P = 0.006).
conclusionsAdministration of crushed 200/50 mg lopinavir/ritonavir tablets to children significantly reduced lopinavir and ritonavir exposure with a decrease in AUC by 45% and 47%, respectively. The administration of crushed tablets would require higher doses and therapeutic drug monitoring to ensure adequate lopinavir exposure in patients requiring this practice. The use of crushed lopinavir/ritonavir tablets should be avoided, if possible.
Indexed as
Identifiers
What OpenQuestion holds
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.