Trial reportThe lancet. HIV2025
ART-free HIV-1 remission in children with in-utero HIV-1 after very early ART (IMPAACT P1115): a multicentre, open-label, phase 1/2 proof-of-concept study.
Trial report in The lancet. HIV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02140255 (Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission), which is not on this map. Cited by 6 papers.
What it found
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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.
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study
Who cites it
6 citing papers in PubMed.
- HIV cure after HCT: 7 horses seem to be on the mark.Blood advances · 2026Article
- Dynamics of Intact and Defective Human Immunodeficiency Virus Type 1 (HIV-1) Proviruses During Decades of Suppressive Antiretroviral Treatment in Young Adults With Perinatal HIV.The Journal of infectious diseases · 2026Article
- Recommendations from the 2nd Consensus Workshop on Analytical Treatment Interruption in HIV Research Trials.The lancet. HIV · 2026Article
- HIV Cure Research: Ethical and Real-World Practical Considerations for Pediatric and Adolescent Populations.Journal of the Pediatric Infectious Diseases Society · 2026Article
- Persistent Seronegativity and Absence of Intact Proviruses Despite Prolonged Initial Viremia in Early-Treated Perinatal HIV Infection.Open forum infectious diseases · 2026Article
- Maternal-Child Human Immunodeficiency Virus Clinical Trials Networks across the Ages.Clinics in perinatology · 2024Review
Corrections and comments
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Authors and funding
25 authors.
Funding
Abstract
backgroundWe hypothesised that initiating antiretroviral therapy (ART) soon after birth could limit HIV-1 reservoirs and promote ART-free remission. This study aims to assess remission in children with in-utero HIV-1 infection who received very early ART as neonates by performing analytical treatment interruption (ATI).
methodsIMPAACT P1115 is an ongoing, open-label, proof-of-concept study at 30 research sites in 11 countries across Africa, Asia, and the Americas. Neonates (≥34 weeks gestational age) at high risk for in-utero HIV-1 were eligible. Neonates born to mothers with untreated HIV-1 (cohort 1) or mothers who might have been on ART (cohort 2) initiated three-drug oral nevirapine-based ART (6mg/kg per dose orally twice a day) within 48 h of birth (cohort 1), three-drug nevirapine-based prophylaxis (≥8 mg/kg per dose orally once a day), or nevirapine-based ART after HIV-1 diagnosis by age 10 days (cohort 2). Coformulated ritonavir 75 mg/m
findingsAmong 54 children with in-utero HIV-1 enrolled between Jan 23, 2015, and Dec 14, 2017, six (11%) children (four girls, two boys; one in cohort 1, five in cohort 2) met criteria and underwent ATI at a median age of 5·5 years. Two children had early rebound at 3·4 weeks and 9·4 weeks. Four reached ART-free remission (67%; exact 95% CI 22-96), one of whom had late viral rebound at 79·3 weeks. All three children with viral rebound successfully resuppressed HIV-1 RNA below the assay limit on ART. Mild symptoms of acute retroviral syndrome occurred in two participants during rebound and resolved with ART resumption.
interpretationThis study shows that ART-free remission for 48 weeks or longer is achievable with very early ART in children with in-utero HIV-1, but close monitoring for viral rebound and acute retroviral syndrome during ATI is needed. These findings, observed in resource-constrained countries, exhibit the feasibility of testing at birth and initiating very early ART, show the potential to limit HIV-1 reservoirs for ART-free remission, and inform future remission strategies.
fundingThe US National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the US National Institute of Mental Health.
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