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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
White:  49
Countries:  Argentina, Brazil, Canada, France, Italy, Portugal, Puerto Rico, Romania, South Africa, Spain, Thailand, United Kingdom, United States