Evidence map›Paper›PMID 25072616›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2014

Risk factors for preterm birth among HIV-infected pregnant Ugandan women randomized to lopinavir/ritonavir- or efavirenz-based antiretroviral therapy.

Catherine A Koss, Paul Natureeba, Albert Plenty, Flavia Luwedde, Julia Mwesigwa, Veronica Ades, Edwin D Charlebois, Tamara D Clark, Jane Achan, Theodore Ruel and 4 more

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

Trial report in Journal of acquired immune deficiency syndromes (1999), 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 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
4.7field-weighted citation impact, top 5% 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

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Nutrients · 2020
    Pooled it
  5. Adverse Pregnancy Outcomes Among Women Who Conceive on Antiretroviral Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. A Scoping Review of Preterm Births in Sub-Saharan Africa: Burden, Risk Factors and Outcomes.International journal of environmental research and public health · 2022
    Article
  19. Effectiveness and safety of available treatments for COVID-19 during pregnancy: a critical review.The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians · 2022
    Review
  20. 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

14 authors at 6 institutions in 3 countries.

Catherine A Koss*HIV/AIDS Division, Department of Medicine, San Francisco General Hospital, University of California, San Francisco, San Francisco, CA; †Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda; ‡Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, San Francisco, CA; §Department of Obstetrics and Gynecology, New York University, New York, NY; ‖Medical Research Council Unit, The Gambia; ¶Division of Infectious Diseases, Department of Pediatrics, University of California, San Francisco, San Francisco, CA; #Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda; and **Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.
Paul Natureeba
Albert Plenty
Flavia Luwedde
Julia Mwesigwa
Veronica Ades
Edwin D Charlebois
Tamara D Clark
Jane Achan
Theodore Ruel
Bridget Nzarubara
Moses R Kamya
Diane V Havlir
Deborah Cohan
Makerere University · UGUniversity of California, San Francisco · USMRC Unit the Gambia · GMNew York University · USSan Francisco AIDS Foundation · USSan Francisco General Hospital · 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
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 T32 AI060530NIAID NIH HHS UM1 AI069496NICHD NIH HHS K23 HD060459NICHD NIH HHS P01 HD059454NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundProtease inhibitor-based antiretroviral therapy (ART) has been associated with preterm birth in some studies. We examined risk factors for preterm birth among women randomized to lopinavir/ritonavir (LPV/r)- or efavirenz (EFV)-based ART.

methodsThis was a planned secondary analysis of the PROMOTE-Pregnant Women and Infants Study, an open-label, randomized controlled trial comparing the risk of placental malaria among HIV-infected, ART-naive pregnant Ugandan women assigned to initiate LPV/r- or EFV-based ART at 12-28 weeks gestation. Gestational age was determined based on last menstrual period and ultrasound biometry. All women received bednets and trimethoprim-sulfamethoxazole. Stillbirths, spontaneous abortions, and multiple gestations were excluded from the primary analysis. Potential risk factors for preterm birth (<37 weeks gestation) were evaluated by univariate and multivariate logistic regression.

resultsThree hundred fifty-six women were included in this analysis. At enrollment, median gestational age was 21 weeks and median CD4 cell count was 368 cells per cubic millimeter. 14.7% of deliveries in the EFV arm and 16.2% in the LPV/r arm were preterm. Preterm birth was associated with gestational weight gain below 0.1 kg/week versus 0.1 kg/week or more [odds ratio (OR) = 2.49; 95% confidence interval (CI): 1.38 to 4.47; P = 0.003]. Neither ART regimen of LPV/r versus EFV (OR = 1.12; 95% CI: 0.63 to 2.00; P = 0.69) nor placental malaria (OR = 0.74; 95% CI: 0.38 to 1.44; P = 0.37) was associated with preterm birth.

conclusionsLPV/r was not associated with an increased risk of preterm birth compared with EFV. However, interventions are needed to address modifiable risk factors for preterm birth, such as nutritional status (ClinicalTrials.gov, NCT00993031).

Indexed as

AdolescentAdultAlkynesAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBenzoxazinesCyclopropanesFemaleHIV InfectionsHumansInfant, NewbornLopinavirMalePregnancyPremature BirthRisk FactorsAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenzLopinavirRitonavir

Identifiers

PMID25072616
PMCPMC4414017
OpenAlexW1987681191

What OpenQuestion holds

Textmetadata
LicenceTDM
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.