Metabolic effects of initiating lopinavir/ritonavir-based regimens among young children

AIDS. 2018 Oct 23;32(16):2327-2336. doi: 10.1097/QAD.0000000000001980.


Objective: The aim of this study was to estimate the long-term metabolic effects of initiating a lopinavir/ritonavir (LPV/r)-based regimen as a first-line therapy for HIV-infected children less than 3 years of age in resource-limited settings.

Design: A prospective cohort study after conclusion of the P1060 randomized clinical trials ( Identifier: NCT00307151), with an overall follow-up of 7 years.

Methods: Longitudinal total cholesterol and triglyceride measures were compared between 222 and 227 children randomized to initiate LPV/r and nevirapine (NVP)-based regimens, respectively. Adipokines (adiponectin and leptin) and biomarkers of inflammation [C-reactive protein and interleukin (IL)-6], microbial translocation (lipopolysaccharide) and immune activation (sCD14), measured in 117 participants at a median of 45 weeks of follow-up, were also compared by a randomized arm.

Results: Mean total cholesterol and the percentage of participants with borderline or high total cholesterol was higher in the LPV/r arm from years 3 to 7 of follow-up than in the NVP arm (adjusted relative differences ranging from 10.9 to 23.4 mg/dl and adjusted relative risks ranging from a 60% increased risk to a more than four-fold increased risk for cholesterol ≥170 mg/dl at 7 years of follow-up). Initiation of a LPV/r-based regimen was not associated with high triglycerides over follow-up or large differences in markers of metabolic syndrome, inflammation, microbial translocation or immune activation.

Conclusion: Given the virologic superiority of LPV/r-based regimens in young children and open questions regarding the roll-out of dolutegravir in resource-limited settings, children are currently being maintained on LPV/r-based regimens. Our results suggest continual assessment of total cholesterol among young children initiating a LPV/r-based regimen to monitor cardiometabolic health.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Anti-HIV Agents / administration & dosage*
  • Blood Chemical Analysis
  • Child, Preschool
  • Female
  • Follow-Up Studies
  • HIV Infections / drug therapy*
  • Humans
  • Infant
  • Lopinavir / administration & dosage*
  • Male
  • Metabolome / drug effects*
  • Metabolomics
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Ritonavir / administration & dosage*


  • Anti-HIV Agents
  • Lopinavir
  • Ritonavir

Associated data