ArticleJournal of acquired immune deficiency syndromes (1999)2020
Raltegravir (RAL) in Neonates: Dosing, Pharmacokinetics (PK), and Safety in HIV-1-Exposed Neonates at Risk of Infection (IMPAACT P1110).
Article in Journal of acquired immune deficiency syndromes (1999), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 22 citations in OpenAlex.
- HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study.The lancet. HIV · 2024Trial
- A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- HIV postnatal prophylaxis and infant feeding policies vary across Europe: results of a Penta survey.HIV medicine · 2025Article
- The urgency of now to end HIV vertical transmission for pregnant and breastfeeding women and their children in Asia and the Pacific.The Lancet regional health. Western Pacific · 2024Review
- Post-Natal Anti-Retroviral Prophylaxis for Neonates Born to Mothers Living with Resistant HIV Infection.Sultan Qaboos University medical journal · 2023Article
- Novel Approaches to Postnatal Prophylaxis to Eliminate Vertical Transmission of HIV.Global health, science and practice · 2023Article
- Optimising neonatal antiretroviral therapy using raltegravir: a qualitative analysis of healthcare workers' and caregivers' perspectives.BMJ paediatrics open · 2022Article
- Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097.Journal of acquired immune deficiency syndromes (1999) · 2020Article
- Low raltegravir transfer into the breastmilk of a woman living with HIV.AIDS (London, England) · 2020Article
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Authors and funding
16 authors at 12 institutions in 2 countries.
Funding
Abstract
backgroundAdequate pharmacokinetic and safety data in neonates are lacking for most antiretroviral agents. Raltegravir is a selective HIV-1 integrase strand transfer inhibitor available in a granule formulation suitable for use in neonates and young infants as prophylaxis or treatment of HIV infection.
methodsIMPAACT P1110 is a phase 1, multicenter, noncomparative dose-finding study of raltegravir in infants exposed to HIV-1 infection. A 2-cohort adaptive design was utilized where pharmacokinetic data from infants in cohort 1 who received 2 single doses of raltegravir 3 mg/kg were included in population modeling and simulations to guide selection of a daily dose for infants in cohort 2.
resultsA total of 52 infants enrolled in IMPAACT 1110: cohort 1 (N = 16) and cohort 2 (N = 36). Using simulations based on population PK modeling incorporating cohort 1 data, the following daily dosing regimen was selected for study: 1.5 mg/kg daily from birth through day 7; 3 mg/kg twice daily from days 8-28 of life; and 6 mg/kg twice daily after 4 weeks of age through 6 weeks of age. The geometric mean protocol exposure targets for AUC, Ctrough, and Cmax were met or slightly exceeded in all infants. The chosen neonatal raltegravir dosing regimen was safe and well tolerated in full-term neonates during treatment over the first 6 weeks of life and follow-up to age 24 weeks.
conclusionsRaltegravir can be safely administered to full-term infants using the daily dosing regimen studied. This regimen is not recommended for use in premature infants in a new version of P1110.
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