Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
  • Print
  • Share
  • E-mail
-
 
Approval Date:  12/16/2011
 
Trade Name:  Prezista
 
Generic or Proper Name (*):  darunavir
 
Indications Studied:  Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg
 
Therapeutic Category:  Antiviral
 
Ages Studied:  3 - <6 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  27
 
No Centers:  11
 
No Countries:  5
 
BPCA(B), PREA(P):  B, P
 
Unknown:  0
 
Countries:  Argentina, Brazil, Kenya, South Africa, India
 
-
-