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Published in: BMC Infectious Diseases 1/2007

Open Access 01-12-2007 | Research article

Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial: differences between Europe and the USA

Authors: Marie-Louise Newell, Sharon Huang, Simona Fiore, Claire Thorne, Laurent Mandelbrot, John L Sullivan, Robert Maupin, Isaac Delke, D Heather Watts, Richard D Gelber, Coleen K Cunningham, the PACTG 316 Study Team

Published in: BMC Infectious Diseases | Issue 1/2007

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Abstract

Background

Rates of mother-to-child transmission of HIV-1 (MTCT) have historically been lower in European than in American cohort studies, possibly due to differences in population characteristics. The Pediatric AIDS Clinical Trials Group Protocol (PACTG) 316 trial evaluated the effectiveness of the addition of intrapartum/neonatal nevirapine in reducing MTCT in women already receiving antiretroviral prophylaxis. Participation of large numbers of pregnant HIV-infected women from the US and Western Europe enrolling in the same clinical trial provided the opportunity to identify and explore differences in their characteristics and in the use of non-study interventions to reduce MTCT.

Methods

In this secondary analysis, 1350 women were categorized according to enrollment in centres in the USA (n = 978) or in Europe (n = 372). Factors associated with receipt of highly active antiretroviral therapy and with elective caesarean delivery were identified with logistic regression.

Results

In Europe, women enrolled were more likely to be white and those of black race were mainly born in Sub-Saharan Africa. Women in the US were younger and more likely to have previous pregnancies and miscarriages and a history of sexually transmitted infections.
More than 90% of women did not report symptoms of their HIV infection; however, more women from the US had symptoms (8%), compared to women from Europe (4%). Women in the US were less likely to have HIV RNA levels <400 copies/ml at delivery than women enrolling in Europe, and more likely to receive highly active antiretroviral therapy, and to start therapy earlier in pregnancy. The elective caesarean delivery rate in Europe was 61%, significantly higher than that in the US (22%). Overall, 1.48% of infants were infected and there was no significant difference in the rate of transmission between Europe and the US despite the different approaches to treatment and delivery.

Conclusion

These findings confirm that there are important historical differences between the HIV-infected pregnant populations in Western Europe and the USA, both in terms of the characteristics of the women and their obstetric and therapeutic management. Although highly active antiretroviral therapy predominates in pregnancy in both settings now, population differences are likely to remain.

Trial registration

NCT00000869
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Metadata
Title
Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial: differences between Europe and the USA
Authors
Marie-Louise Newell
Sharon Huang
Simona Fiore
Claire Thorne
Laurent Mandelbrot
John L Sullivan
Robert Maupin
Isaac Delke
D Heather Watts
Richard D Gelber
Coleen K Cunningham
the PACTG 316 Study Team
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Infectious Diseases / Issue 1/2007
Electronic ISSN: 1471-2334
DOI
https://doi.org/10.1186/1471-2334-7-60

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Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine