Trial reportThe New England journal of medicine2012
Three postpartum antiretroviral regimens to prevent intrapartum HIV infection.
Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 85 papers, 1 of them a synthesis that pooled 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.
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.
Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection
Who cites it
85 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Safety and efficacy of major antiviral and immune therapies in pregnancy for maternal viral infections: evidence synthesis of maternal and neonatal outcomes.Frontiers in medicine · 2026Pooled it
- Impact of point-of-care maternal viral load testing at delivery on vertical HIV transmission risk assessment and neonatal prophylaxis: a cluster randomized trial.Journal of the International AIDS Society · 2025Trial
- Maintenance darunavir/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE 168 MONOGEST study.The Journal of antimicrobial chemotherapy · 2023Trial
- Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study.The lancet. HIV · 2021Trial
- Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.The lancet. HIV · 2020Trial
- Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results From the HPTN 040/PACTG 1043 Trial.The Pediatric infectious disease journal · 2018Trial
- Congenital Cytomegalovirus and HIV Perinatal Transmission.The Pediatric infectious disease journal · 2018Trial
- Combined evaluation of sexually transmitted infections in HIV-infected pregnant women and infant HIV transmission.PloS one · 2018Trial
- Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates.Journal of acquired immune deficiency syndromes (1999) · 2017Trial
- Cytomegalovirus Urinary Shedding in HIV-infected Pregnant Women and Congenital Cytomegalovirus Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Trial
- Effect of co-trimoxazole on mortality in HIV-exposed but uninfected children in Botswana (the Mpepu Study): a double-blind, randomised, placebo-controlled trial.The Lancet. Global health · 2017Trial
- Randomized noninferiority trial of two maternal single-dose nevirapine-sparing regimens to prevent perinatal HIV in Thailand.AIDS (London, England) · 2015Trial
- Chlamydia and Gonorrhea in HIV-Infected Pregnant Women and Infant HIV Transmission.Sexually transmitted diseases · 2015Trial
- Raltegravir pharmacokinetics in neonates following maternal dosing.Journal of acquired immune deficiency syndromes (1999) · 2014Trial
- Syphilis in pregnant women living with HIV/AIDS in Brazil and the relationship between coinfection and mother-to-child transmission of HIV.BMC public health · 2025Article
- COVID-19-related ARDS in a young infant with uncontrolled HIV after delay in EID.AIDS research and therapy · 2025Article
- HIV postnatal prophylaxis and infant feeding policies vary across Europe: results of a Penta survey.HIV medicine · 2025Article
- Preventing perinatal HIV acquisition; current gaps and future perspectives.Current opinion in HIV and AIDS · 2024Review
- Article
- La réduction du risque d'infection périnatale chez les nouveau-nés de mères dont les soins prénatals étaient inappropriés.Paediatrics & child health · 2023Review
25 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors.
Funding
Abstract
backgroundThe safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants.
methodsWithin 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth.
resultsA total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P=0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P=0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P=0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P<0.001 for both comparisons with the other groups).
conclusionsIn neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two- or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others; ClinicalTrials.gov number, NCT00099359.).
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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.