Document Detail

Long-term outcomes for HIV-infected infants less than 6 months of age at initiation of lopinavir/ritonavir combination antiretroviral therapy.
MedLine Citation:
PMID:  21297419     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To investigate the longitudinal pharmacokinetics, safety and efficacy of lopinavir/ritonavir (LPV/r) in HIV-infected infants initiating combination antiretroviral therapy (cART) between 2 weeks and 6 months of age.
METHOD: A prospective, open-label, multicenter Phase I/II study of LPV/r-based cART at a dose of 300/75 mg/m(2)/dose LPV/r twice daily. Intensive pharmacokinetic sampling at 12 months of age and quarterly predose LPV concentrations were collected and safety, virologic and immunologic responses were monitored every 4-12 weeks up to 252 weeks.
RESULTS: Thirty-one HIV-infected infants enrolled into two age cohorts, 14 days to <6 weeks and 6 weeks to <6 months; 29 completed ≥48 weeks of follow-up (median = 123 weeks, range 4-252). At 12 months of age, median LPV area under the curve was comparable for both age cohorts and similar to older children and adults. At week 48, 22 of 31 patients (71%) had HIV-1 RNA <400 copies/ml and 11 of 15 (73%) had <50 copies/ml; 29 of 31 achieved HIV-1 RNA <400 copies/ml on study treatment and 19 (66%) remained durably suppressed until the end of study; viral suppression correlated with a higher percentage of predose time points exceeding the LPV target of 1 μg/ml (92 vs. 71%, P = 0.002).
CONCLUSION: LPV/r at 300/75 mg/m(2)/dose as part of a cART regimen resulted in viral suppression through 96 weeks of treatment in >65% of young infants. Due to initially low LPV exposure in infants <6 weeks of age, frequent dose adjustment for weight gain is advisable and consideration should be given to studying a higher dose for very young infants.
Ellen G Chadwick; Ram Yogev; Carmelita G Alvero; Michael D Hughes; Rohan Hazra; Jorge A Pinto; Brian L Robbins; Barbara E Heckman; Paul E Palumbo; Edmund V Capparelli;
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  AIDS (London, England)     Volume:  25     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-03-03     Completed Date:  2011-07-07     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  643-9     Citation Subset:  IM; X    
Division of Infectious Diseases, Children's Memorial Hospital, Northwestern University's Feinberg School of Medicine, Chicago, Illinois, USA.
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MeSH Terms
Drug Administration Schedule
Drug Therapy, Combination
HIV Infections / drug therapy,  immunology*,  virology
HIV Protease Inhibitors / administration & dosage,  pharmacokinetics*
HIV-1 / immunology*
Infant, Newborn
Pyrimidinones / administration & dosage,  pharmacokinetics*
Ritonavir / administration & dosage,  pharmacokinetics*
Treatment Outcome
Viral Load
Grant Support
1 U01 AI068616/AI/NIAID NIH HHS; 5 U01 AI41110/AI/NIAID NIH HHS; AI068632/AI/NIAID NIH HHS; HHSN267200800001C//PHS HHS; N01-HD-8-0001/HD/NICHD NIH HHS; U01 AI068632/AI/NIAID NIH HHS; U01 AI068632-03/AI/NIAID NIH HHS
Reg. No./Substance:
0/HIV Protease Inhibitors; 0/Lopinavir; 0/Pyrimidinones; 0/Ritonavir

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