HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examines the impact of fosamprenavir as part of an ART on virological, immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this is shown to be true, changes in HCV viral load or biological characteristics could be demonstrated.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Collaborator: ViiV Healthcare
• Treatments: Fosamprenavir; Ritonavir

Criteria

Inclusion Criteria:

• Age >18 yo

• HIV/HCV co-infected patients with HCV detectable viremia in 2 determinations separated at least by 6 months.

• HCV genotype 1

• Currently receiving ART including 2NRTI+1 PI/r (excluding FPV) or 1 NNRTI, without changes in the last 6 months

• HIV RNA < 50 copies/mL for the last 6 months

Exclusion Criteria:

• Previous anti HCV treatment

• Foreseeable HCV treatment in the next 12 months

• Acute HCV infection

• Active opportunistic infection

• HIV with FPV resistance mutations

• Current or previous treatment with FPV

• Chronic hepatitis B

• Current alcohol consumption greater than 20 g per day