Evidence map›Paper›PMID 30124366›Full record

ReviewJournal of women's health (2002)2019

Beyond "Vessels and Vectors": A Global Review of Registered HIV-Related Clinical Trials with Pregnant Women.

Marisha N Wickremsinhe, Margaret O Little, Alice S Carter, Kristen A Sullivan, Anne D Lyerly

Abstract readReview
In one paragraph

Review in Journal of women's health (2002), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. The HIV Reservoir and Immune Landscape Across the Life Course of Women: Implications for Cure Strategies.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Importance of Prospective Studies in Pregnant and Breastfeeding Women Living With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
  9. 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

5 authors.

Marisha N Wickremsinhe1 Kennedy Institute of Ethics, Georgetown University, Washington, District of Columbia.
Margaret O Little1 Kennedy Institute of Ethics, Georgetown University, Washington, District of Columbia.
Alice S Carter1 Kennedy Institute of Ethics, Georgetown University, Washington, District of Columbia.
Kristen A Sullivan2 Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Anne D Lyerly2 Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Funding

The PHASES Project: Pregnancy and HIV/AIDS-Seeking Equitable StudyR01AI108368 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAY, SUZANNE LOUISE, LYERLY, ANNE DRAPKIN · 2015 to 2024
$6.4M
Integrating Decision Making Studies into HIV Cure Trials: A real-time longitudinal assessmentR01AI127024 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HENDERSON, GAIL E · 2016 to 2019
$2.2M
NIAID NIH HHS R01 AI108368NIAID NIH HHS R01 AI127024
6 · The paper itself

Abstract

backgroundSince the early 1990s, the HIV research agenda has prioritized to some degree the inclusion of pregnant women. However, concerns remain regarding the extent to which pregnant women's own health needs are addressed, representation in trials of HIV preventives or treatments for comorbidities, and equitable study of newer medications during pregnancy.

methodsWe employed a keyword search of the International Clinical Trials Registry Platform to identify interventional HIV-related trials conducted with pregnant women between January 2001 and December 2015. Retained trials were coded according to several key variables (e.g., study endpoints, trial phase, study compound) and analyzed using information provided in the database.

resultsIn total, 63 trials studying use of a pharmacological compound during pregnancy were conducted across 35 countries and sponsored by 74 unique organizations, including pharmaceutical companies. Of trials analyzed, 86% (n = 54) listed maternal outcomes as a primary endpoint. More than 35% (n = 23) of trials assessed pharmacokinetic parameters of a study compound during pregnancy. Of 45 trials specifically studying HIV-related medication(s), just 4% (n = 2) focused on HIV preventives. One trial studied tuberculosis in HIV-infected pregnant women; 11 studied malaria. On average, medications were studied during pregnancy 4.4 years after licensure.

conclusionsOur findings demonstrate that trials with pregnant women are conducted across a range of countries and sponsors, and much progress has been made to better address pregnant women's own health needs in HIV research. However, our findings confirm other concerns, for example, lack of HIV preventives studied and the lag between medication licensure and study during pregnancy.

Indexed as

Clinical Trials as TopicPregnant PeopleAdultAnti-HIV AgentsFemaleHIV InfectionsHumansInfectious Disease Transmission, VerticalPregnancyPregnancy Complications, InfectiousYoung AdultAnti-HIV Agentsclinical researchHIVpharmaceuticalsPMTCTpregnant women

Identifiers

PMID30124366
PMCPMC6343191

What OpenQuestion holds

Textmetadata
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.