A Study to evaluate the effect and safety of experimental drugs ABT-493/ABT-530 in adults with Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDIT...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-005577-20

A Study to evaluate the effect and safety of experimental drugs ABT-493/ABT-530 in adults with Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

The primary objectives of this study are to are to compare the SVR12 rates (12-week sustained virologic response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) of 8 or 12 weeks of treatment with ABT-493/ABT-530 combination in HCV genotype 1 – 6 infected subjects with HIV-1 co-infection to a pre-defined threshold, based on the historical SVR12 rate of the current standard of care (i.e., sofosbuvir/ledipasvir for 12 weeks or grazoprevir/elbasvir for 12 weeks) and to assess the safety of treatment with the combination regimen ABT-493/ABT-530 for 8 or 12 weeks in HCV genotype 1 – 6 infected subjects with HIV-1 co-infection.


Critère d'inclusion

  • Hepatitis C Virus Infection
  • Human Immunodeficiency Virus Infection
  • Chronic Hepatitis C
  • Compensated Cirrhosis and Non-cirrhotics