Evidence map›Paper›PMID 18784455›Full record

ArticleAIDS (London, England)2008

The pharmacokinetics and pharmacogenomics of efavirenz and lopinavir/ritonavir in HIV-infected persons requiring hemodialysis.

Samir K Gupta, Susan L Rosenkranz, Yoninah S Cramer, Susan L Koletar, Lynda A Szczech, Valerianna Amorosa, Stephen D Hall

Abstract readMulticenter Study
In one paragraph

Article in AIDS (London, England), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Quadruple therapy for asymptomatic COVID-19 infection patients.Expert review of anti-infective therapy · 2020
    Article
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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

7 authors.

Samir K GuptaIndiana University School of Medicine, Indianapolis, Indiana, USA. sgupta1@iupui.edu
Susan L Rosenkranz
Yoninah S Cramer
Susan L Koletar
Lynda A Szczech
Valerianna Amorosa
Stephen D Hall

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
YOHIMBINE AS A MODEL OF ORTHOSTATIC INTOLERANCEM01RR000095 · NCRR · VANDERBILT UNIVERSITY · PI DRAKE, WONDER P. · 1985 to 2008
$38.3M
ZINC AND CA EDTA THERAPY OF PLUMBISMM01RR000052 · NCRR · JOHNS HOPKINS UNIVERSITY · PI BELCHER, HAROLYN MILLICENT EDITH · 1985 to 2007
$37.3M
The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)UM1AI069465 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner, Amita Gupta · 2012 to 2026
$34.1M
ZOSUQUIDAR TRIHYDROCHLORIDE DURING CONVENTIONAL INDUCTION AND POST-REMISSIONM01RR000750 · NCRR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI RODRIGUEZ, HENRY · 1985 to 2008
$25.5M
YOGA, IMMUNE FUNCTION, AND HEALTHM01RR000034 · NCRR · OHIO STATE UNIVERSITY · PI PESAVENTO, TODD · 1985 to 2008
$22.7M
Zosuquidar trihydrochloride for acute myeloid leukemia &refractory anemiaM01RR000080 · NCRR · UNIVERSITY HOSPITALS OF CLEVELAND · PI DAVIS, PAMELA B · 1985 to 2007
$22.2M
HIV/AIDS Clinical Trials UnitU01AI069484 · NIAID · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2007 to 2011
$14.6M
WOMEN'S HEALTH AGENDAU01AI025859 · NIAID · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI GOLDMAN, MITCHELL · 1987 to 2008
$14.5M
NCRR NIH HHS M01 RR000034NCRR NIH HHS M01 RR000052NCRR NIH HHS M01 RR000080NCRR NIH HHS M01 RR000095NCRR NIH HHS M01 RR000750NCRR NIH HHS RR000080NCRR NIH HHS RR000095NCRR NIH HHS RR00034NCRR NIH HHS RR00052NCRR NIH HHS RR00750NIAID NIH HHS AI38855NIAID NIH HHS AI68636NIAID NIH HHS P30 AI045008NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI025879NIAID NIH HHS U01 AI032775NIAID NIH HHS U01 AI032783NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI046370NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069447NIAID NIH HHS U01 AI069465NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069484NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069447NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069484
6 · The paper itself

Abstract

objectiveTo evaluate the pharmacokinetics and pharmacogenomics of efavirenz (EFV) and lopinavir/ritonavir (LPV/RTV) in HIV-infected persons requiring hemodialysis.

designProspective, observational study of HIV-infected hemodialysis patients receiving one 600 mg tablet daily of EFV (N = 13) or three 133.3/33.3 mg capsules twice daily of LPV/RTV (N = 13).

methodsTwenty-four-hour EFV and 12-h LPV/RTV pharmacokinetics were assessed. Geometric mean ratios were calculated using historical controls with normal renal function. The effects of several candidate gene polymorphisms were also explored.

resultsThe geometric mean [95% confidence interval (CI); percentage of coefficient of variation (% CV)] Cmin, Cmax, and area under the curve (AUC) for the EFV group were 1.81 microg/ml (0.93, 3.53; 103%), 5.04 microg/ml (3.48, 7.29; 72%), and 71.5 microg h/ml (43.2, 118.3; 93%), respectively. These parameters were 2.76 microg/ml (1.86, 4.11; 53%), 8.45 microg/ml (6.41, 11.15; 52%), and 69.6 microg h/ml (55.6, 87.2; 37%) for LPV and 0.08 microg/ml (0.05, 0.14; 63%), 0.58 microg/ml (0.44, 0.76; 41%), and 3.74 microg h/ml (2.91, 4.80; 37%) for RTV. The AUC geometric mean ratios (90% CI) for EFV, LPV, and RTV were 132% (89, 197), 81% (67, 97), and 92% (76, 111), respectively. LPV Cmin was lower than expected in the hemodialysis group. Higher EFV concentrations were associated with the CYP2B6 516G>T polymorphism.

conclusionThe pharmacokinetics of EFV and LPV/RTV in hemodialysis suggests that no dosing adjustments are necessary in treatment-naive patients. As HIV-infected hemodialysis patients are disproportionately black, the increased frequency of the CYP2B6 516G>T polymorphism may lead to higher EFV levels. The potentially lower LPV trough levels in this population suggest that LPV/RTV should be used with caution in protease-inhibitor-experienced patients.

Indexed as

HIV-1Renal DialysisAdultAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDrug CombinationsFemaleHIV InfectionsHIV Protease InhibitorsHumansKidney Failure, ChronicLopinavirMaleMiddle AgedAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDrug CombinationsefavirenzHIV Protease InhibitorsLopinavirPyrimidinonesReverse Transcriptase InhibitorsRitonavir

Identifiers

PMID18784455
PMCPMC2675161

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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.