Evidence mapPaperPMID 39219495Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Lipid and Glucose Profiles in Pregnant Women With HIV on Tenofovir-based Antiretroviral Therapy.

Ahizechukwu C Eke, Sean S Brummel, Muktar H Aliyu, Lynda Stranix-Chibanda, George U Eleje, Ifeanyichukwu U Ezebialu, Violet Korutaro, Deo Wabwire, Allen Matubu, Tapiwa Mbengeranwa and 11 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Ahizechukwu C EkeDivision of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-0070-9840
Sean S BrummelCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Muktar H AliyuDepartment of Health Policy and Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Lynda Stranix-ChibandaChild and Adolescent Health Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
George U ElejeDepartment of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria.
Ifeanyichukwu U EzebialuDepartment of Obstetrics and Gynecology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Amaku, Anambra State, Nigeria.
Violet KorutaroBaylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.
Deo WabwireMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Allen MatubuFaculty of Medicine and Health Sciences, University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.
Tapiwa MbengeranwaFaculty of Medicine and Health Sciences, University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.
Nahida ChakhtouraEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.
Lameck ChinulaDivision of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Katie McCarthyFHI 360, Durham, North Carolina, USA.
Kevin KnowlesFrontier Science Foundation, Amherst, New York, USA.
Chelsea KrotjeFrontier Science Foundation, Amherst, New York, USA.
Macrae F LintonDivision of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Kelly E DooleyDivision of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Paul E SaxDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Todd BrownDivision of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-8599-278X
Shahin LockmanDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-5384-9716
IMPAACT 2010/VESTED Study Team

Funding

IMPAACT Leadership GroupUM1AI068632 · NIAID · JOHNS HOPKINS UNIVERSITY · 2021 to 2025
$88.9M
SDMC - IMPAACT Leadership GroupUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2021 to 2025
$61.1M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials UnitUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · 2021 to 2025
$23.6M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 to 2025
$21.9M
International Maternal, Adolescent and Pediatric Therapeutics Clinical Trials NetworkUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$21.2M
Non-Coding RNA Analytical CoreP01HL116263 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · 2022 to 2025
$17.7M
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · 2021 to 2025
$10.4M
Tennessee Center for AIDS Research (TN-CFAR)P30AI110527 · VANDERBILT UNIVERSITY MEDICAL CENTER · 2025 to 2025
$1.7M
Integrated proteomic and metabolomic biomarker profiling for understanding metabolic syndrome in pregnant women living with HIV on Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir (TLD)DP1HD115433 · JOHNS HOPKINS UNIVERSITY · 2025 to 2025
$573k
Mentoring Investigators in HIV and Tuberculosis Therapeutics ResearchK24AI150349 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · 2023 to 2025
$295k
Mentoring in Patient-Oriented HIV Research in the Era of Universal ARTK24AI131928 · BRIGHAM AND WOMEN'S HOSPITAL · 2025 to 2025
$179k
Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentIMPAACT NetworkInternational Maternal Pediatric Adolescent AIDS Clinical Trials NetworkNational Institute of Allergy and Infectious DiseasesNHLBI NIH HHS P01 HL116263NIAID NIH HHS K24 AI131928NIAID NIH HHS K24 AI150349NIAID NIH HHS P30 AI110527NIAID NIH HHS U01 AI069530NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106716NICHD NIH HHS DP1 HD115433NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001INICHD NIH HHS K23 HD104517NIH HHS K23HD104517NIMH NIH HHS
6 · The paper itself

Abstract

backgroundTenofovir alafenamide (TAF)-based antiretroviral therapy (ART) regimens have been associated with adverse changes in lipid and glucose profiles compared with tenofovir disoproxil fumarate (TDF)-based ART, but data in pregnancy are limited. We evaluated metabolic markers in pregnant women with human immunodeficiency virus (HIV) after starting TAF- versus TDF-based ART.

methodsWe analyzed data within the IMPAACT 2010/VESTED trial, which demonstrated better pregnancy outcomes in pregnant women randomized to initiate TAF/Emtricitabine/Dolutegravir (TAF/FTC + DTG; n = 217) or TDF/FTC + DTG (n = 215). We measured non-fasting plasma concentrations of glucose, total-cholesterol, low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), lipoprotein (a), and triglycerides from samples collected 8 weeks after enrollment. We employed linear regression models to estimate by-arm mean differences.

resultsIn total, 219 participants enrolled in the DTG arms in Zimbabwe and Uganda: 109 in the TAF/FTC + DTG and 110 in the TDF/FTC + DTG arms. At study entry, mean gestational age was 22.6 weeks, median HIV-1 RNA was 711 copies/mL, and mean age was 25.8 years. By 8 weeks, mean total cholesterol was 12 mg/dL higher in women randomized to TAF/ FTC + DTG versus TDF/FTC + DTG (95% confidence interval [CI]: 3.8, 21.1). Pregnant women in the TAF/FTC + DTG arm had higher mean LDL-C (7.1 mg/dL, 95% CI: .2, 14.0), triglycerides (12.3 mg/dL, 95% CI: 1.8, 22.7), lipoprotein (a) (7.3 mg/dL, 95% CI: 1.1, 13.6), and lower mean HDL-C (2.8 mg/dL, 95% CI: .1, 5.6) compared to the TDF/FTC + DTG arm.

conclusionsPregnant women randomized to start TAF/FTC + DTG had higher lipids than those randomized to TDF/FTC + DTG within 8 weeks of ART initiation. However, lipid levels were within normal reference ranges.

Indexed as

AdenineAnti-HIV AgentsBlood GlucoseHIV InfectionsLipidsPregnancy Complications, InfectiousTenofovirAdultAlanineEmtricitabineFemaleHumansPregnancyUgandaYoung AdultZimbabweAdenineAlanineAnti-HIV AgentsBlood GlucoseEmtricitabineLipidsTenofovirtenofovir alafenamideHIVhyperlipidemiametabolic complicationspregnancytenofovir

Identifiers

PMID39219495
PMCPMC11912963

What Socratic holds

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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 Socratic graph.