Trial reportThe Pediatric infectious disease journal2021
Pharmacokinetics and Safety of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in HIV-infected Children With Severe Acute Malnutrition in Sub-Saharan Africa: IMPAACT Protocol P1092.
Trial report in The Pediatric infectious disease journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01818258 (IMPAACT 1092), which is not on this map. Cited by 4 papers.
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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.
IMPAACT 1092: Phase IV Evaluation Of The Steady State Pharmacokinetics Of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1-Infected Children
Who cites it
4 citing papers in PubMed, 6 citations in OpenAlex.
- Prevalence and factors contributing to severe undernutrition in children on antiretroviral therapy (ART) drugs in Ilala District, Tanzania.Scientific reports · 2026Article
- Effects of Combination Antiretroviral Therapy and Nutritional Rehabilitation on Growth in Children Aged 6-36 Months with Severe Acute Malnutrition in IMPAACT Protocol P1092.Journal of the Pediatric Infectious Diseases Society · 2024Article
- Micronutrients and nutritional status among children living with HIV with and without severe acute malnutrition: IMPAACT P1092.BMC nutrition · 2023Article
- Lopinavir-menthol co-crystals for enhanced dissolution rate and intestinal absorption.Journal of drug delivery science and technology · 2022Article
Corrections and comments
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Authors and funding
21 authors at 13 institutions in 6 countries.
Funding
Abstract
backgroundSevere acute malnutrition (SAM) may alter the pharmacokinetics (PK), efficacy, and safety of antiretroviral therapy. The phase IV study, IMPAACT P1092, compared PK, safety, and tolerability of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in children with and without SAM. MATERIALS AND
methodsChildren living with HIV 6 to <36 months of age with or without World Health Organization (WHO)-defined SAM received ZDV, 3TC, and LPV/r syrup for 48 weeks according to WHO weight band dosing. Intensive PK sampling was performed at weeks 1, 12, and 24. Plasma drug concentrations were measured using liquid chromatography tandem mass spectrometry. Steady-state mean area under the curve (AUC0-12h) and clearance (CL/F) for each drug were compared. Grade ≥3 adverse events were compared between cohorts.
resultsFifty-two children were enrolled across 5 sites in Africa with 44% (23/52) female, median age 19 months (Q1, Q3: 13, 25). Twenty-five children had SAM with entry median weight-for-height Z-score (WHZ) -3.4 (IQR -4.0, -3.0) and 27 non-SAM had median WHZ -1.0 (IQR -1.8, -0.1). No significant differences in mean AUC0-12h or CL/F were observed (P ≥ 0.09) except for lower 3TC AUC0-12h (GMR, 0.60; 95% CI, 0.4-1.0; P = 0.047) at week 12, higher ZDV AUC0-12h (GMR, 1.52; 1.2-2.0; P = 0.003) at week 24 in the SAM cohort compared with non-SAM cohort. Treatment-related grade ≥3 events did not differ significantly between cohorts (24.0% vs. 25.9%).
conclusionPK and safety findings for ZDV, 3TC, and LPV/r support current WHO weight band dosing of syrup formulations in children with SAM.
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