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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/21/2011
 
Trade Name:  Isentress
 
Generic or Proper Name (*):  raltegravir
 
Indications Studied:  In combination with other antiretroviral agents for the treatment of HIV-1 infection
 
Therapeutic Category:  Antiviral
 
Ages Studied:  2-<12 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  126
 
No Centers:  40
 
No Countries:  5
 
BPCA(B), PREA(P):  B, P
 
Unknown:  0
 
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