Trial reportThe lancet. HIV2024
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.
Trial report in The lancet. HIV, 2024. 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 17 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
17 citing papers in PubMed, 20 citations in OpenAlex.
- VRC01 with antiretroviral initiation in infants is well tolerated, and higher concentrations associate with greater HIV-1 DNA declines.Science translational medicine · 2026Trial
- 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.The lancet. HIV · 2025Trial
- Article
- Combination therapy with broadly neutralizing antibodies, antiretroviral therapy and CCR5 blockade limits viral reservoir seeding in infant macaque model of HIV.Nature microbiology · 2026Article
- Increases in total HIV-1 nucleic acid in whole blood precede plasma RNA rebound during pediatric analytical treatment interruption.AIDS (London, England) · 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
- Review
- Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 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
- Cellular Tropism and Viral Genetics in Appendix Tissue Reservoirs of Subtype C HIV-1-Infected Aviremic Persons.The Journal of infectious diseases · 2025Article
- Human models that inform antiretroviral therapy-free remission with perinatally acquired HIV infection.Current opinion in HIV and AIDS · 2025Review
- Immune signatures and biomarkers of viral control in early-treated children with HIV: insights informing intervention.Current opinion in HIV and AIDS · 2025Review
- Intact HIV DNA decays in children with and without complete viral load suppression.PLoS pathogens · 2025Article
- HIV cure research contributions from Africa in the last three decades.Frontiers in immunology · 2025Review
- Research Toward a Cure for Perinatal HIV.Clinics in perinatology · 2024Review
- HIV reservoir and premature aging: risk factors for aging-associated illnesses in adolescents and young adults with perinatally acquired HIV.PLoS pathogens · 2024Article
Corrections and comments
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Authors and funding
22 authors at 14 institutions in 4 countries.
Funding
Abstract
backgroundInfants born with HIV-1 require lifelong antiretroviral therapy (ART). We aimed to assess whether very early ART in neonates might restrict HIV-1 reservoirs, an important step towards ART-free remission.
methodsIMPAACT P1115 is an ongoing, phase 1/2, proof-of-concept study in which infants were enrolled at 30 research clinics in 11 countries (Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, the USA, Zambia, and Zimbabwe) into two cohorts. Infants at least 34 weeks' gestational age at high risk for in-utero HIV-1 with either untreated maternal HIV-1 (cohort 1) or who were receiving pre-emptive triple antiretroviral prophylaxis outside of the study (maternal ART permissible; cohort 2) were included. All infants initiated treatment within 48 h of life. Cohort 1 initiated three-drug nevirapine-based ART, and cohort 2 initiated three-drug nevirapine-based prophylaxis then three-drug nevirapine-based ART following HIV diagnosis by age 10 days. We added twice-daily coformulated oral ritonavir 75 mg/m
findingsBetween Jan 23, 2015, and Dec 14, 2017, 440 infants were included in cohort 1 and 20 were included in cohort 2. 54 of these infants (34 from cohort 1 and 20 from cohort 2) had confirmed in-utero HIV-1 and were enrolled to receive study ART. 33 (61%) of 54 infants were female and 21 (39%) were male. The estimated probability of maintaining undetectable plasma RNA through to 2 years was 33% (95% CI 17-49) in cohort 1 and 57% (28-78) in cohort 2. Among infants maintaining protocol-defined virological control criteria through to study week 108, seven of 11 (64%, 95% CI 31-89) in cohort 1 and five of seven (71%, 29-96) in cohort 2 had no detected HIV-1 DNA. Ten of 12 (83%, 52-100) in cohort 1 and all seven (100%, 59-100) in cohort 2 tested HIV-1 antibody-negative at week 108. Among 54 infants initiated on very early ART, ten (19%; six in cohort 1 and four in cohort 2) met all criteria for possible analytical treatment interruption. Reversible grade 3 or 4 adverse events occurred in 15 (44%) of 34 infants in cohort 1 and seven (35%) of 20 infants in cohort 2.
interpretationVery early ART for in-utero HIV-1 can achieve sustained virological suppression in association with biomarkers indicating restricted HIV-1 reservoirs by age 2 years, which might enable potential ART-free remission.
fundingNational Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health.
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What OpenQuestion holds
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.