Evidence map›Paper›PMID 20002783›Full record

ArticleHIV medicine2010

Lopinavir protein binding in HIV-1-infected pregnant women.

F T Aweeka, A Stek, B M Best, C Hu, D Holland, A Hermes, S K Burchett, J Read, M Mirochnick, E V Capparelli and 1 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in HIV medicine, 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 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 7% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.

  1. Pooled it
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  13. Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women.Journal of acquired immune deficiency syndromes (1999) · 2015
    Article
  14. Article
  15. Article
  16. Etravirine in CSF is highly protein bound.The Journal of antimicrobial chemotherapy · 2013
    Article
  17. Review
  18. Review
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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 7 institutions in 1 country.

F T AweekaDrug Research Unit, University of California, San Francisco, CA 94143-0622, USA. faweeka@sfghsom.ucsf.edu
A Stek
B M Best
C Hu
D Holland
A Hermes
S K Burchett
J Read
M Mirochnick
E V Capparelli
International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1026s Protocol Team
University of California, San Diego · USAbbott Fund · USBoston University Academy · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USHarvard University · USUniversity of California, San Francisco · USUniversity of Southern California · US

Funding

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 and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
ZIDOVUDINE &LAMIVUDINE &NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFM01RR001271 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KESSLER, DAVID A · 1985 to 2006
$22.7M
YOGA INDUCED CHANGES IN BRAIN GABA LEVELSM01RR000533 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI ANTMAN, KAREN · 1985 to 2008
$19.4M
Miami Treatment and Prevention Clinical Trials Unit (CTU)UM1AI069477 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI JAYAWEERA, DUSHYANTHA, SCOTT, GWENDOLYN BARBARA · 2012 to 2020
$9.2M
Miami HIV/AIDS Clinical Therapeutic and Vaccine Trial UnitU01AI069477 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI FISCHL, MARGARET A · 2007 to 2011
$7.1M
PEDIATRIC PHARMACOLOGY RESEARCH UNITU01HD031318 · NICHD · UNIVERSITY OF CALIFORNIA SAN DIEGO · PI CONNOR, JAMES D · 1994 to 2003
$1.7M
NCRR NIH HHS 5 M01 RR01271NCRR NIH HHS M01 RR000533NCRR NIH HHS M01 RR001271NCRR NIH HHS M01 RR00533NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS U01AI068632NIAID NIH HHS UM1 AI069477NICHD NIH HHS N01-HD-3-3365NICHD NIH HHS U01 HD031318NICHD NIH HHS U01-HD-031318-11
6 · The paper itself

Abstract

backgroundPregnancy may alter protein binding (PB) of highly bound protease inhibitors due to changes in plasma concentrations of albumin and alpha-1 acid glycoprotein (AAG). Small changes in PB can greatly impact the fraction of drug unbound (FU) exerting pharmacological effect. We report lopinavir (LPV) PB during third trimester (antepartum, AP) compared to > or =1.7 weeks postpartum (PP) to determine if FU changes compensate for reduced total concentrations reported previously.

methodsP1026s enrolled women receiving LPV/ritonavir, soft gel capsules 400/100 mg or 533/133 mg twice daily. LPV FU, albumin and AAG were determined AP and PP.

resultsAP/PP samples were available from 29/25 women respectively with all but one woman receiving the same dose AP/PP. LPV FU was increased 18% AP vs. PP (mean 0.96+/-0.16% AP vs. 0.82+/-0.21% PP, P=0.001). Mean protein concentrations were reduced AP (AAG=477 mg/L; albumin=3.28 mg/dL) vs. PP (AAG=1007 mg/L; albumin=3.85 mg/dL) (P<0.0001 for each comparison). AAG concentration correlated with LPV binding. Total LPV concentration did not correlate with LPV FU AP or PP. However, higher LPV concentration PP was associated with reduced PB and higher FU after adjustment for AAG.

conclusionsLPV FU was higher and AAG lower AP vs. PP. The 18% increase in LPV FU AP is smaller than the reduction in total LPV concentration reported previously and is not of sufficient magnitude to eliminate the need for an increased dose during pregnancy.

Indexed as

HIV-1Acute-Phase ProteinsAdolescentAdultAntiretroviral Therapy, Highly ActiveDrug Therapy, CombinationFemaleHIV InfectionsHIV Protease InhibitorsHumansLopinavirPregnancyPregnancy Complications, InfectiousPregnancy Trimester, ThirdProspective StudiesProtein BindingAcute-Phase ProteinsHIV Protease InhibitorsLopinavirPyrimidinonesRitonavir

Identifiers

PMID20002783
PMCPMC2874627
OpenAlexW2007977191

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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.