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This study will test an experimental drug named GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) for the possible treatment of human immunodeficiency virus (HIV) infection in children and a...

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-002345-39

This study will test an experimental drug named GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) for the possible treatment of human immunodeficiency virus (HIV) infection in children and adolescents. The purpose of this study is to determine the concentration of GS-9883 in your child’s body, and confirm the safety, tolerability and dose of GS-9883/F/TAF in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age)

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Extrait

The primary objectives of this study are: - To evaluate the steady state pharmacokinetics (PK) for GS-9883 and confirm the dose of the GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) fixed dose combination (FDC) in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age) - To evaluate the safety and tolerability of the GS-9883/F/TAF FDC through Week 24 in HIV-1 infected, virologically suppressed adolescents and children

Critère d'inclusion

  • Human Immunodeficiency Virus (HIV-1) Infection

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