Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses
Confirmation of Chronic HCV infection
Confirmation of Chronic HIV-1 infection
On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA
Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Subjects must be naive to treatment for chronic HCV infection
You may not be if
Known or suspected cirrhosis
History of any other clinically significant chronic liver disease
A history consistent with decompensated liver disease.
Use of any prohibited medications as defined by the protocol
Pregnant or nursing female or male with pregnant female partner
Contraindication to PEG or RBV therapy (for Part B)
Clinically relevant drug or alcohol abuse
Clareo Health | Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
