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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
12/18/2008
Trade Name:
Prezista
Generic or Proper Name (*):
darunavir
Indications Studied:
Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents
Therapeutic Category:
Antiviral
Ages Studied:
6 - <18 years
Study #:
1
Study Type:
Safety/Pharmacokinetic
Study Design:
Open Label/Traditional Pharmacokinetic
No Patients:
80
No Centers:
12
No Countries:
9
BPCA(B), PREA(P):
B, P
Asian:
0
Black:
24
Other:
6
White:
43
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
7
Non-Hispanic/Non Latino:
73
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