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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/23/2008
 
Trade Name:  Aptivus
 
Generic or Proper Name (*):  tipranavir
 
Indications Studied:  Co-administered with ritonavir for combination antiretroviral in patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor
 
Therapeutic Category:  Antiviral
 
Ages Studied:  2-18 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  110
 
No Centers:  24
 
No Countries:  8
 
BPCA(B), PREA(P):  B, P
 
Asian:  2
 
Black:  33
 
Other:  0
 
White:  80
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  61
 
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