Evidence map›Paper›PMID 25426808›Full record

Trial reportAIDS (London, England)2015

Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women.

Deborah Cohan, Paul Natureeba, Catherine A Koss, Albert Plenty, Flavia Luwedde, Julia Mwesigwa, Veronica Ades, Edwin D Charlebois, Monica Gandhi, Tamara D Clark and 5 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% 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
NCT03302299 phase4completednot on this mapstarted 2017, after this paper: background citation

URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence

TypeinterventionalSponsorUniversity of California, San FranciscoRan2017 to 2021Enrolled302ConditionsTuberculosis, HIV/AIDS, Alcohol AbuseArmsIsoniazid 300 Mg ORAL TABLET, Pyridoxine 25 Mg Oral Tablet
NCT05333679 nacompletednot on this mapstarted 2022, after this paper: background citation

Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2022 to 2025Enrolled200ConditionsRisk ReductionArmsUTRA, UTRA feedback
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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  12. Formulation, Optimization, andCurrent pharmaceutical design · 2025
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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

15 authors at 5 institutions in 3 countries.

Deborah CohanaDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California, USA bMakerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda cHIV/AIDS Division, San Francisco General Hospital dCenter for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California eDepartment of Obstetrics and Gynecology, New York University, New York, USA fMedical Research Council Unit, The Gambia gDepartment of Pediatrics, University of California, San Francisco, San Francisco, California, USA hDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Paul Natureeba
Catherine A Koss
Albert Plenty
Flavia Luwedde
Julia Mwesigwa
Veronica Ades
Edwin D Charlebois
Monica Gandhi
Tamara D Clark
Bridget Nzarubara
Jane Achan
Theodore Ruel
Moses R Kamya
Diane V Havlir
University of California, San Francisco · USSan Francisco General Hospital · USMakerere University · UGMRC Unit the Gambia · GMNew York University · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 1988 to 2026
$93.6M
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
Training in HIV Translational ResearchT32AI060530 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Diane V Havlir · 2005 to 2026
$6.4M
Plugging Hair ARV Levels as Adherence Biomarkers into HIV Prevention TrialsR01AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA · 2012 to 2021
$5.6M
“Hair Lengthening”: Using Hair Levels to Interpret Long-Acting PrEP Studies.R37AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2023 to 2026
$3.2M
HIV Disease Progression in African ChildrenK23HD060459 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI RUEL, THEODORE DUMONT · 2010 to 2014
$627k
NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI098472NIAID NIH HHS R37 AI098472NIAID NIH HHS T32 AI060530NIAID NIH HHS UM1 AI069496NICHD NIH HHS K23 HD060459NICHD NIH HHS K23 P01 HD059454NICHD NIH HHS P01 HD059454NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

objectiveCombination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4⁺ cell counts. We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda.

designRandomized clinical trial.

methodsWe performed a planned secondary analysis comparing viral load suppression (HIV-1 RNA ≤400 copies/ml), safety, and HIV transmission to infants in a trial designed to test the hypothesis that lopinavir/ritonavir versus efavirenz-based ART would reduce placental malaria (PROMOTE, ClinicalTrials.gov, NCT00993031). HIV-infected, ART-naive pregnant women at 12-28 weeks gestation and any CD4⁺ cell count were randomized. ART was provided and participants were counseled to breastfeed for 1 year postpartum.

resultsThe median age of the 389 study participants was 29 years; median CD4⁺ cell count was 370 cells/μl. At delivery, virologic suppression was 97.6% in the efavirenz arm and 86.0% in the lopinavir/ritonavir arm (P < 0.001). At 48 weeks postpartum, 91.0% of women on efavirenz and 88.4% on lopinavir/ritonavir had viral suppression (P = 0.49). Grade 1 or 2 gastrointestinal adverse events were higher among women on lopinavir/ritonavir versus efavirenz. Only two infants acquired HIV (both in the lopinavir/ritonavir arm), and HIV-free infant survival was similar between study arms: 92.9% (lopinavir/ritonavir) versus 97.2% (efavirenz) (P = 0.10).

conclusionVirologic suppression at delivery was higher with an efavirenz versus lopinavir/ritonavir-based regimen. However, women in both arms achieved high levels of virologic suppression through 1 year postpartum and the risk of transmission to infants was low.

Indexed as

AdultAlkynesAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBenzoxazinesBreast FeedingCD4 Lymphocyte CountCyclopropanesFemaleHIV-1HIV InfectionsHumansInfantInfant, NewbornInfectious Disease Transmission, VerticalLopinavirAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenzLopinavirRitonavir

Identifiers

PMID25426808
PMCPMC4428759
OpenAlexW2036584642

What OpenQuestion holds

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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.