TY - JOUR
T1 - Efavirenz liquid formulation in human immunodeficiency virus-infected children
AU - Starr, Stuart E.
AU - Fletcher, Courtney V.
AU - Spector, Stephen A.
AU - Brundage, Richard C.
AU - Yong, Florence H.
AU - Douglas, Steven D.
AU - Flynn, Patrizia M.
AU - Kline, Mark W.
PY - 2002/7/23
Y1 - 2002/7/23
N2 - 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.
AB - 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.
KW - Antiretroviral therapy
KW - Efavirenz
KW - Pediatric human immunodeficiency virus infection
KW - Pharmacokinetics
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U2 - 10.1097/00006454-200207000-00011
DO - 10.1097/00006454-200207000-00011
M3 - Article
C2 - 12237599
AN - SCOPUS:0036020187
VL - 21
SP - 659
EP - 663
JO - Pediatric Infectious Disease Journal
JF - Pediatric Infectious Disease Journal
SN - 0891-3668
IS - 7
ER -