Evidence map›Paper›PMID 26202768›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women.

Angela Colbers, Brookie Best, Stein Schalkwijk, Jiajia Wang, Alice Stek, Carmen Hidalgo Tenorio, David Hawkins, Graham Taylor, Regis Kreitchmann, Sandra Burchett and 8 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 37% 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
NCT00825929 recruitingnot on this map

Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)

TypeobservationalSponsorRadboud University Medical CenterRan2009 to 2026Enrolled176ConditionsHIV Infections
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. 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

18 authors at 15 institutions in 7 countries.

Angela ColbersDepartment of Pharmacy.
Brookie BestUC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences & School of Medicine, University of California San Diego.
Stein SchalkwijkDepartment of Pharmacy Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen.
Jiajia WangCenter for Biostatistics in AIDS Research, Harvard School of Public Health.
Alice StekMaternal Child and Adolescent/Adult Center, University of Southern California School of Medicine, Los Angeles.
Carmen Hidalgo TenorioDepartment of Infectious Diseases, Hospital Universitario Virgen de las Nieves Granada, Spain.
David HawkinsChelsea and Westminster Hospital.
Graham TaylorImperial College Healthcare NHS Trust, London, United Kingdom.
Regis KreitchmannHIV/AIDS Research Department, Irmandade da Santa Casa de Misericordia de Porto Alegre, Brazil.
Sandra BurchettBoston Children's Hospital, Harvard Medical School.
Annette HaberlDepartment of Infectious Diseases, Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany.
Kabamba KabeyaDepartment of Infectious Diseases, Saint-Pierre University Hospital, Brussels, Belgium.
Marjo van KasterenDepartment of Internal Medicine, St Elisabeth Ziekenhuis, Tilburg, The Netherlands.
Elizabeth SmithMaternal, Adolescent, and Pediatric Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Edmund CapparelliUC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences & School of Medicine, University of California San Diego.
David BurgerDepartment of Pharmacy.
Mark MirochnickBoston University School of Medicine, Massachusetts.
PANNA Network and the IMPAACT 1026 Study Team
Boston University · USCancer Research And Biostatistics · USCentre Hospitalier Universitaire de Saint-Pierre · BEChelsea and Westminster Hospital · GBElisabeth-TweeSteden Ziekenhuis · NLGoethe University Frankfurt · DEHarvard University · USHospital Universitario Virgen de las Nieves · ESImperial College Healthcare NHS Trust · GBIrmandade da Santa Casa de Misericórdia de São Paulo · BRNational Institute of Allergy and Infectious Diseases · USRadboud University Nijmegen · NLUniversity of California, San Diego · USUniversity of Montana · 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
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
University of Puerto Rico Clinical Trials UnitUM1AI069415 · NIAID · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI FEBO, IRMA LUZ, SANTANA-BAGUR, JORGE L. · 2012 to 2021
$15.2M
USE OF OXANDROLONE TO IMPROVE FUNCTION IN CHRONIC SCIM01RR016587 · NCRR · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI FLOREZ, HERMES · 2002 to 2005
$6.8M
NCATS NIH HHS UL1 TR001082NCRR NIH HHS M01 RR016587NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1AI068632NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI106716NIAID NIH HHS UM1AI106716
6 · The paper itself

Abstract

objectiveTo describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)-infected women during pregnancy and post partum.

methodsHIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery. Cord blood samples and matching maternal blood samples were taken at delivery. The data were collected in 2 studies: P1026 (United States) and PANNA (Europe). Pharmacokinetic parameters were calculated.

resultsEighteen women were included in the analysis. Most women (12; 67%) received 150 mg of maraviroc twice daily with a protease inhibitor, 2 (11%) received 300 mg twice daily without a protease inhibitor, and 4 (22%) had an alternative regimen. The geometric mean ratios for third-trimester versus postpartum maraviroc were 0.72 (90% confidence interval, .60-.88) for the area under the curve over a dosing interval (AUCtau) and 0.70 (0.58-0.85) for the maximum maraviroc concentration. Only 1 patient showed a trough concentration (Ctrough) below the suggested target of 50 ng/mL, both during pregnancy and post partum. The median ratio of maraviroc cord blood to maternal blood was 0.33 (range, 0.03-0.56). The viral load close to delivery was <50 copies/mL in 13 women (76%). All children were HIV negative at testing.

conclusionsOverall maraviroc exposure during pregnancy was decreased, with a reduction in AUCtau and maximum concentration of about 30%. Ctrough was reduced by 15% but exceeded the minimum Ctrough target concentration. Therefore, the standard adult dose seems sufficient in pregnancy. CLINICAL TRIALS REGISTRATION: NCT00825929 and NCT000422890.

Indexed as

AdultAnti-HIV AgentsBlood Chemical AnalysisCyclohexanesEuropeFemaleHIV InfectionsHumansMaravirocPregnancyPregnancy Complications, InfectiousTriazolesUnited StatesYoung AdultAnti-HIV AgentsCyclohexanesMaravirocTriazolesHIVmaravirocMTCTpharmacokineticspregnancy

Identifiers

PMID26202768
PMCPMC4614410
OpenAlexW2142839536

What OpenQuestion holds

Textmetadata
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.