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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  01/18/2012
 
Trade Name:  Viread
 
Generic or Proper Name (*):  tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of HIV infection in combination with other antiretroviral agents
 
Therapeutic Category:  Antiviral
 
Ages Studied:  2-<12 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label/Active Control
 
No Patients:  97
 
No Centers:  9
 
No Countries:  3
 
BPCA(B), PREA(P):  B,P
 
White:  9
 
American Indian/Alaska Native:  2
 
Countries:  US (6), Panama (1), United Kingdom (2)
 
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