HIV infection, AIDS, Chronic hepatitis C infection
Conditions
Interventions
Patients receive sofosbuvir 400mg plus daclatasvir 60mg once daily for 12 weeks. In patients receiving antiretroviral therapy with protease inhibitor plus booster, dose of daclatasvir is adjusted to
Sponsors
National center for global health and medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Hemophiliacs infected with HIV and HCV genotype 3 Patients did not complete treatment or treatment failure with IFN An HCV RNA positive at screening HIV RNA less than 50 copies per mL for at least 8 weeks prior to screening CD4 cell count must be more than 200 cells per micro liter for at least 8 weeks prior to screening Men must agree to follow contraception for the duration of treatment with study drugs and 14 weeks post treatment completion Patients agree to take study drugs that are not approved to use as a combination even though both drugs are approved for each in HCV treatment
Exclusion criteria
Exclusion criteria: Decompensated liver disease Severe renal impairment eGFR less than 30mL per min per 1.73m2 HBsAg seropositive Presence of active AIDS defining opportunistic infections to treat Use of prohibited treatments rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, dexamethasone, St. John's wort containing food Any other medical, psychiatric or social reason wich, in the opinion of the investigator would make the subject inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is a sustained virologic response at week 12 after the end of therapy. | — |
Countries
Japan
Contacts
Public ContactHaruka Uemura
National center for global health and medicine AIDS clinical center
Outcome results
None listed