Evidence map›Paper›PMID 34369908›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2021

Brief Report: Vaginal Viral Shedding With Undetectable Plasma HIV Viral Load in Pregnant Women Receiving 2 Different Antiretroviral Regimens: A Randomized Clinical Trial.

Lisa M Frenkel, R Leavitt Morrison, Trevon L Fuller, Maria Isabel Gouvêa, Maria de Lourdes Benamor Teixeira, Robert W Coombs, David E Shapiro, Mark Mirochnick, Roslyn Hennessey, Kyle Whitson and 2 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 46% 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.

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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

12 authors at 9 institutions in 2 countries.

Lisa M FrenkelCenter for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, WA.
R Leavitt MorrisonCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA.
Trevon L FullerInfectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Maria Isabel GouvêaInfectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Maria de Lourdes Benamor TeixeiraInfectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Robert W CoombsLaboratory Medicine and Pathology; and.
David E ShapiroCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA.
Mark MirochnickDepartment of Pediatrics, Boston University School of Medicine, Boston, MA.
Roslyn HennesseyWestat, Rockville, MD.
Kyle WhitsonFrontier Science, Amherst, NY; and.
Nahida ChakhtouraMaternal and Pediatric Infectious Diseases Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
Esaú C JoãoInfectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Hospital Federal dos Servidores do Estado · BRCancer Research And Biostatistics · USBoston University · USEmory University Hospital · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USFrontier Science & Technology Research Foundation · USFundação Oswaldo Cruz · BRUniversity of Washington · USWestat (United States) · 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 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
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
NIAID NIH HHS P30 AI027757NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001I
6 · The paper itself

Abstract

backgroundPregnant women using antiretrovirals (ARVs) may have persistent vaginal viral shedding, which could be associated with sexual and perinatal HIV transmission. However, there are scant data on vaginal viral load (VVL) in pregnant women with undetectable plasma viral load (PVL).

methodsThis study was a post hoc analysis of an open-label randomized trial to evaluate the virologic response of 2 ART regimens. The participants were ART-naive women living with HIV initiating ART regimens between 20 and 36 weeks of pregnancy recruited at 19 clinical sites in 6 countries. Participants were randomized to receive 400 mg of raltegravir 2 times a day or 600 mg of efavirenz 4 times a day in addition to 150 mg of lamivudine and 300 mg of zidovudine 2 times a day. VVL and PVL tests were performed at every study visit. The primary outcome measures were HIV-1 PVL and VVL at maternal study week 4 and rates of perinatal HIV transmission.

resultsA total of 408 were enrolled, of whom 323 had VVL samples 4 weeks after enrollment and were included in this analysis. Among women with undetectable/nonquantifiable PVL during ART, the overall rate of quantifiable VVL at week 4 was 2.54% (7/275). Of the 275 with nonquantifiable PVL, 99.1% (115/116) and 96.2% (153/159) had nonquantifiable VVL in the efavirenz and raltegravir arms, respectively. None of the 7 women with quantifiable VVL at the week 4 study visit transmitted HIV to their infants.

conclusionsDetectable VVL in pregnant women with undetectable/nonquantifiable PVL while receiving ART was rare and not associated with perinatal HIV transmission.

Indexed as

Virus SheddingAdultAlkynesAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBenzoxazinesCyclopropanesDrug Resistance, ViralFemaleHIV InfectionsHumansInfantInfectious Disease Transmission, VerticalLamivudinePregnancyPregnancy Complications, InfectiousAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenzLamivudineRaltegravir PotassiumZidovudine

Identifiers

PMID34369908
PMCPMC8547747
OpenAlexW3192193851

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.