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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/20/2008
 
Trade Name:  Kaletra
 
Generic or Proper Name (*):  lopinavir/ ritonavir
 
Indications Studied:  Use in combination with other antiretroviral agents for HIV-1 infection
 
Therapeutic Category:  Antiviral
 
Ages Studied:  14 days - 18 years
 
Study #:  3
 
Study Type:  Efficacy/Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  100
 
No Centers:  10
 
No Countries:  6
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  57
 
Other:  2
 
White:  9
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  32
 
Non-Hispanic/Non Latino:  68
 
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