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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/26/2012
 
Trade Name:  Intelence
 
Generic or Proper Name (*):  etravirine
 
Indications Studied:  Treatment of HIV-1 infection in combination with other antiretroviral agents
 
Therapeutic Category:  Antiviral
 
Ages Studied:  6 - < 18 years
 
Study #:  2
 
Study Type:  Efficacy/Safety/Tolerability
 
Study Design:  Open Label
 
No Patients:  101
 
No Centers:  42
 
No Countries:  13
 
BPCA(B), PREA(P):  B,P
 
White:  49
 
Countries:  Argentina, Brazil, Canada, France, Italy, Portugal, Puerto Rico, Romania, South Africa, Spain, Thailand, United Kingdom, United States
 
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