Evidence map›Paper›PMID 24958908›Full record

Trial reportThe Journal of infectious diseases2014

Lopinavir/ritonavir-based antiretroviral treatment (ART) versus efavirenz-based ART for the prevention of malaria among HIV-infected pregnant women.

Paul Natureeba, Veronica Ades, Flavia Luwedde, Julia Mwesigwa, Albert Plenty, Pius Okong, Edwin D Charlebois, Tamara D Clark, Bridget Nzarubara, Diane V Havlir and 4 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00993031 (Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 4% 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.

NCT00993031 phase3completednot on this map

Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women

TypeinterventionalSponsorUniversity of California, San FranciscoRan2009 to 2013Enrolled389ConditionsMalaria, HIV InfectionsArmsLopinavir/ritonavir, Efavirenz, Zidovudine, Lamivudine
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

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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

14 authors at 5 institutions in 2 countries.

Paul NatureebaInfectious Diseases Research Collaboration.
Veronica AdesDepartment of Obstetrics and Gynecology, New York University, New York City.
Flavia LuweddeInfectious Diseases Research Collaboration.
Julia MwesigwaInfectious Diseases Research Collaboration.
Albert PlentyDepartment of Medicine.
Pius OkongUgandan Ministry of Health.
Edwin D CharleboisDepartment of Medicine.
Tamara D ClarkDepartment of Medicine.
Bridget NzarubaraInfectious Diseases Research Collaboration.
Diane V HavlirDepartment of Medicine.
Jane AchanDepartment of Pediatrics.
Moses R KamyaDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Deborah CohanDepartment of Obstetrics and Gynecology, University of California-San Francisco.
Grant DorseyDepartment of Medicine.
Infectious Diseases Research Collaboration · UGMakerere University · UGMinistry of Health · UGNew York University · USUniversity of California, San Francisco · US

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
The immunologic consequences of prenatal exposure to malariaP01HD059454 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2008 to 2017
$22.6M
NIAID NIH HHS UM1 AI069496NICHD NIH HHS P01 HD059454NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundHuman immunodeficiency virus (HIV)-infected pregnant women are at increased risk of malaria and its complications. In vitro and in vivo data suggest that the HIV protease inhibitors lopinavir/ritonavir may have potent antimalarial activity. We sought to evaluate whether lopinavir/ritonavir-based antiretroviral therapy (ART) reduced the risk of placental malaria.

methodsHIV-infected, ART-naive pregnant women were enrolled between gestational weeks 12 and 28 and randomly assigned to receive lopinavir/ritonavir-based or efavirenz-based ART. Women received daily trimethoprim-sulfamethoxazole prophylaxis and insecticide-treated bed nets at enrollment and were followed up to 1 year after delivery. The primary outcome was placental malaria, defined by the detection of malaria parasites, using microscopy or polymerase chain reaction (PCR) analysis of placental blood specimens. Secondary outcomes included placental malaria, defined by histopathologic results; adverse birth outcomes; incidence of malaria; and prevalence of asymptomatic parasitemia. Analyses were done using an intention-to-treat approach.

resultsOf 389 subjects randomly assigned to a treatment group, 377 were followed through to delivery. There was no significant difference in the risk of placental malaria, as defined by thick smear or PCR findings, between the lopinavir/ritonavir-based and efavirenz-based ART arms (7.4% vs 9.8%; P = .45). Similarly, there were no differences in secondary outcomes between the 2 treatment arms.

conclusionsLopinavir/ritonavir-based ART did not reduce the risk of placental or maternal malaria or improve birth outcomes, compared with efavirenz-based ART. CLINICAL TRIALS REGISTRATION: NCT00993031.

Indexed as

AdolescentAdultAlkynesAnti-HIV AgentsAntimalarialsAntiretroviral Therapy, Highly ActiveBenzoxazinesCyclopropanesFemaleHIV InfectionsHumansInfant, NewbornLopinavirMalariaPregnancyPregnancy Complications, InfectiousAlkynesAnti-HIV AgentsAntimalarialsBenzoxazinesCyclopropanesefavirenzLopinavirRitonavirTrimethoprim, Sulfamethoxazole Drug CombinationefavirenzHIVlopinavir/ritonavirmalariapregnancy

Identifiers

PMID24958908
PMCPMC4296178
OpenAlexW2169632381

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.