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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/24/2010
 
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:  12 - <18 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  87
 
No Centers:  18
 
No Countries:  2
 
BPCA(B), PREA(P):  B, P
 
Asian:  25
 
Black:  0
 
Other:  17
 
White:  45
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
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