Efavirenz liquid formulation in human immunodeficiency virus-infected children.
BACKGROUND
This study determined the safety, pharmacokinetics, antiviral activity and immunologic effects of efavirenz liquid formulation, nelfinavir and nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected children, 3 to 9 years of age.


METHODS
Plasma HIV-1 RNA and lymphocyte subsets were measured at various intervals after initiation of therapy. Pharmacokinetic studies were performed at Week 2, and doses of efavirenz and nelfinavir were adjusted if area under the curve values fell outside specified target ranges.


RESULTS
This combination of antiretrovirals was well-tolerated. Pharmacokinetic values were similar to those observed in a previous study of older children who received efavirenz capsules in combination with nelfinavir and NRTIs. After 48 weeks of therapy 63% of subjects had plasma HIV RNA levels of <400 copies/ml, and 58% had <50 copies/ml in an intent-to-treat analysis. CD4 cell count and percentage rose significantly over this time, whereas the number of activated CD8 cells declined.


CONCLUSIONS
Combination therapy with efavirenz liquid formulation, nelfinavir and NRTIs is an attractive treatment option for HIV-infected children >3 years of age who are unable to take efavirenz capsules.
Starr
Stuart E
SE
Division of Infectious and Immunologic Diseases, Abramson Research Center, The Children's Hospital of Philadelphia, PA 19104, USA. starr@email.chop.edu
Fletcher
Courtney V
CV
Spector
Stephen A
SA
Brundage
Richard C
RC
Yong
Florence H
FH
Douglas
Steven D
SD
Flynn
Patricia M
PM
Kline
Mark W
MW
D000284:Administration, Oral; D000480:Alkynes; D048588:Benzoxazines; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D017320:HIV Protease Inhibitors / Q000008:administration & dosage*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D019888:Nelfinavir / Q000008:administration & dosage*; D010078:Oxazines / Q000008:administration & dosage*; D012367:RNA, Viral / Q000032:analysis; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016019:Survival Analysis; D016896:Treatment Outcome; D019562:Viral Load
D000480:Alkynes; D048588:Benzoxazines; D003521:Cyclopropanes; D017320:HIV Protease Inhibitors; D010078:Oxazines; D012367:RNA, Viral; D019888:Nelfinavir; C098320:efavirenz