Evidence map›Paper›PMID 20632458›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2010

Lopinavir tablet pharmacokinetics with an increased dose during pregnancy.

Brookie M Best, Alice M Stek, Mark Mirochnick, Chengcheng Hu, Hong Li, Sandra K Burchett, Steven S Rossi, Elizabeth Smith, Jennifer S Read, Edmund V Capparelli and 1 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00042289 (Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum), which is not on this map. Cited by 44 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 4 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT00042289 completednot on this map

Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum

TypeobservationalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2003 to 2020Enrolled1,578ConditionsHIV InfectionsArmsatazanavir/cobicistat, darunavir/ritonavir dosage #1, darunavir/ritonavir dosage #2, darunavir/ritonavir dosage #3, elvitegravir/cobicistat
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 4 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Fosamprenavir with Ritonavir Pharmacokinetics during Pregnancy.Antimicrobial agents and chemotherapy · 2020
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Atazanavir pharmacokinetics with and without tenofovir during pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2011
    Trial
  18. Trial
  19. 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

11 authors at 6 institutions in 1 country.

Brookie M BestSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, San Diego, CA, USA. brookie@ucsd.edu
Alice M Stek
Mark Mirochnick
Chengcheng Hu
Hong Li
Sandra K Burchett
Steven S Rossi
Elizabeth Smith
Jennifer S Read
Edmund V Capparelli
International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s Study Team
University of Montana · USCancer Research And Biostatistics · USBoston University · USNational Institute of Allergy and Infectious Diseases · USUniversity of California, San Diego · USUniversity of Southern California · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS 5 U01 AI41110NIAID NIH HHS AI068632NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068632NICHD NIH HHS HHSN267200800001CNIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-8-0001
6 · The paper itself

Abstract

objectiveReduced lopinavir concentrations have been demonstrated with use of the capsule formulation during the third trimester of pregnancy. This study determined lopinavir exposure with an increased dose of the new tablet formulation during the third trimester.

designInternational Maternal Pediatric Adolescent AIDS Clinical Trials 1026s is a prospective nonblinded pharmacokinetic study in HIV-infected pregnant women, including a cohort receiving 2 lopinavir/ritonavir tablets (400 mg/100 mg) twice daily during the second trimester, 3 tablets (600 mg/150 mg) twice daily during the third trimester, and 2 tablets (400 mg/100 mg) twice daily post delivery through 2 weeks postpartum.

methodsSteady-state 12-hour pharmacokinetic profiles were performed during pregnancy and at 2 weeks postpartum. Lopinavir and ritonavir were measured by reverse-phase high-performance liquid chromatography (detection limit, 0.09 mcg/mL).

resultsThirty-three women were studied. Median lopinavir AUC for the second trimester (n = 11), third trimester (n = 33), and postpartum (n = 27) were 72, 96, and 133 mcg x hr/mL, respectively. Median minimum lopinavir concentrations were 3.4, 4.9, and 6.9 mcg/mL.

conclusionsThe higher lopinavir/ritonavir tablet dose (600 mg/150 mg) provided exposure during the third trimester similar to the average AUC (98 mcg x hr x mL(-1) in nonpregnant adults taking 400 mg/100 mg twice daily. The higher dose should be used during the second and third trimesters of pregnancy. Postpartum dosing can be reduced to standard dosing before 2 weeks postpartum.

Indexed as

AdultAnti-HIV AgentsArea Under CurveBody WeightCohort StudiesDose-Response Relationship, DrugDrug Therapy, CombinationEthnicityFemaleGestational AgeHIV InfectionsHumansLopinavirPostpartum PeriodPregnancyPregnancy ComplicationsAnti-HIV AgentsLopinavirPyrimidinonesZidovudine

Identifiers

PMID20632458
PMCPMC3265163
OpenAlexW2077012883

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.