Trial reportJournal of the Pediatric Infectious Diseases Society2015
Pharmacokinetics and 48-Week Safety and Efficacy of Raltegravir for Oral Suspension in Human Immunodeficiency Virus Type-1-Infected Children 4 Weeks to 2 Years of Age.
Trial report in Journal of the Pediatric Infectious Diseases Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Effectiveness and safety of dolutegravir and raltegravir for treating children and adolescents living with HIV: a systematic review.Journal of the International AIDS Society · 2022Pooled it
- Emergence of Resistance in HIV-1 Integrase with Dolutegravir Treatment in a Pediatric Population from the IMPAACT P1093 Study.Antimicrobial agents and chemotherapy · 2022Trial
- Safety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial.The lancet. HIV · 2018Trial
- Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097.Journal of acquired immune deficiency syndromes (1999) · 2020Article
- Outcomes of Integrase Inhibitor-based Antiretroviral Therapy in a Clinical Cohort of Treatment-experienced Children, Adolescents and Young Adults With HIV Infection.The Pediatric infectious disease journal · 2020Observational
- Raltegravir (RAL) in Neonates: Dosing, Pharmacokinetics (PK), and Safety in HIV-1-Exposed Neonates at Risk of Infection (IMPAACT P1110).Journal of acquired immune deficiency syndromes (1999) · 2020Article
- Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.Journal of acquired immune deficiency syndromes (1999) · 2019Article
- Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing.CPT: pharmacometrics & systems pharmacology · 2019Article
- Optimizing Pediatric Dosing Recommendations and Treatment Management of Antiretroviral Drugs Using Therapeutic Drug Monitoring Data in Children Living With HIV.Therapeutic drug monitoring · 2019Review
- High predictive efficacy of integrase strand transfer inhibitors in perinatally HIV-1-infected African children in therapeutic failure of first- and second-line antiretroviral drug regimens recommended by the WHO.The Journal of antimicrobial chemotherapy · 2019Article
- Paediatric Integrase Inhibitor Use in a Real-Life Setting: A Single-Centre Cohort Experience 2009-2018.Clinical drug investigation · 2019Article
- Model-Based Methods to Translate Adolescent Medicine Trials Network for HIV/AIDS Interventions Findings Into Policy Recommendations: Rationale and Protocol for a Modeling Core (ATN 161).JMIR research protocols · 2019Article
- 12-month outcomes of HIV-infected infants identified at birth at one maternity site in Johannesburg, South Africa: an observational cohort study.The lancet. HIV · 2018Observational
- The pharmacological treatment of acute HIV infections in neonates.Expert review of clinical pharmacology · 2017Review
- Impact of Human Immunodeficiency Virus Drug Resistance on Treatment of Human Immunodeficiency Virus Infection in Children in Low- and Middle-Income Countries.The Journal of infectious diseases · 2017Article
- Review
Corrections and comments
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Authors and funding
14 authors at 9 institutions in 1 country.
Funding
Abstract
backgroundIMPAACT P1066 is a Phase I/II open-label multicenter trial to evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of multiple raltegravir (RAL) formulations in human immunodeficiency virus (HIV)-infected youth.
methodsDose selection of the oral suspension formulation for each cohort (IV: 6 months to <2 years and V: 4 weeks to <6 months) was based on review of short-term safety (4 weeks) and intensive PK evaluation. Safety data through Weeks 24 and 48 and Grade ≥3 or serious adverse events (AEs) were assessed. The primary virologic endpoint was achieving HIV RNA <400 copies/mL or ≥1 log10 reduction from baseline at Week 24 (Success). For Cohort IV, optimized background therapy (OBT) could have been initiated with RAL either at study entry or after intensive PK sampling was completed at Day 5-12. An OBT was started when RAL was initiated for Cohort V subjects because they were not permitted to have received direct antiretroviral therapy before enrollment.
resultsTotal accrual was 27 subjects in these 2 cohorts, including 1 subject who was enrolled but never started study drug (excluded from the analyses). The targeted PK parameters (area under the curve [AUC]0-12hr and C12hr) were achieved for each cohort allowing for dose selection. Through Week 48, there were 10 subjects with Grade 3+ AEs. Two were judged related to study drug. There was 1 discontinuation due to an AE of skin rash, 1 event of immune reconstitution syndrome, and no drug-related deaths. At Week 48, for Cohorts IV and V, 87.5% of subjects achieved virologic success and 45.5% had HIV RNA <50 copies/mL. At Week 48, gains in CD4 cells of 527.6 cells/mm(3) and 7.3% were observed.
conclusionsA total of 6 mg/kg per dose twice daily of RAL for oral suspension was well tolerated and showed favorable virologic and immunologic responses.
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Registered trials
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