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J Acquir Immune Defic Syndr. 2019 Apr 23. doi: 10.1097/QAI.0000000000002072. [Epub ahead of print]

Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.

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Makerere University - Johns Hopkins University Research Collaboration, Upper Mulago Hill Road, P. O. Box 23491, Kampala, Uganda.
Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA, United States.
Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive BLVDMSC 7510, Bethesda, Maryland.
University of North Carolina (UNC) Project Lilongwe, P Bag A-104 Lilongwe, Malawi.
Byramiee Jeeieebhoy Government Medical College, 1 Floor, Pathology Museum, Jai Prakash Narayan Road, Pune 411001, India.
Diepklloof Soweto Johannesburg, Gauteng 1864, South Africa.
Department of Obstetrics and Gynecology, University of Zimbabwe, Harare, Zimbabwe.
Anova Health Institute, Johannesburg, South Africa.
School of Public Health & Family medicine, University of Cape Town, South Africa.
Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.
Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland 21205.
Department of Obstetrics and Gynecology, Stellenbosch University, Cape Town, South Africa.
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205.



In the multi-country PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor (PI)-based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a PI regimen, tenofovir/emtricitibine was associated with the more severe outcomes of very LBW (VLBW; <1500g) and very PTD (VPTD; <34 weeks) compared to zidovudine/lamivudine.


We used multivariate logistic regression to further explore these treatment findings, taking into account demographic baseline clinical and post-entry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion.


Among 3333 women delivering at least one live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least one prior PTD. Seventeen percent of newborns were LBW, 1% were VLBW, 17% had PTD, and 3% VPTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included: country, gestational age at entry, maternal age, maternal BMI, prior PTD, history of alcohol use, baseline HIV viral titer, multiple gestation and several obstetric risk factors.


ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical and obstetrical risk factors, which were also associated with these outcomes.

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