| 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 |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
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; |
Related Documents
:
|
16834479 - Self-regulatory processes defend against the threat of death: effects of self-control d... 6933339 - Attitudes and beliefs concerning life and death of elderly persons. 690949 - Measuring fear of death: a reliability study. 6637999 - Decreased mortality among relatives of patients with systemic lupus erythematosus. 8613749 - At least two mechanisms are involved in the death of retinal ganglion cells following t... 22926849 - Neonatal encephalopathy: an inadequate term for hypoxic-ischemic encephalopathy. 20713199 - Laparoscopic management of neonatal paraesophageal hernia with intrathoracic gastric vo... 18001159 - Congenital cerebellar malignant rhabdoid tumor in an infant with junctional epidermolys... 7326369 - The cesarean birth experience: implications for nursing. |
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: 2011-07-28 |
Medline Journal Info:
|
Nlm Unique ID: 8710219 Medline TA: AIDS Country: England |
Other Details:
|
Languages: eng Pagination: 643-9 Citation Subset: IM; X |
Affiliation:
|
Division of Infectious Diseases, Children's Memorial Hospital, Northwestern University's Feinberg School of Medicine, Chicago, Illinois, USA. echadwick@northwestern.edu |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Drug Administration Schedule Drug Therapy, Combination Female HIV Infections / drug therapy, immunology*, virology HIV Protease Inhibitors / administration & dosage, pharmacokinetics* HIV-1 / immunology* Humans Infant Infant, Newborn Male Pyrimidinones / administration & dosage, pharmacokinetics* Ritonavir / administration & dosage, pharmacokinetics* Treatment Outcome Viral Load |
| Grant Support | |
ID/Acronym/Agency:
|
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 |
| Chemical | |
Reg. No./Substance:
|
0/HIV Protease Inhibitors; 0/Pyrimidinones; 0/Ritonavir; 192725-17-0/lopinavir |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Relative time to pregnancy among HIV-infected and uninfected women in the Women's Interagency HIV St...
Next Document: The impact of HIV drug resistance testing on changes to treatment.