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

Fundacion SEIMC-GESIDA

Status and phase: Completed; Phase 4

Conditions: Chronic HIV Infection; HCV Coinfection

Treatments: Drug: Fosamprenavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01222611

2010-023503-10 (EudraCT Number)

GESIDA 6710

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Standard HAART

No Intervention group

Description:

ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI

HAART inlcuding Fos APV/r

Experimental group

Description:

ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir

Treatment:

Drug: Fosamprenavir