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

Phase 4

Completed

• Conditions: Chronic HIV Infection; HCV Coinfection
• Interventions: Drug: Fosamprenavir

• Registration Number: NCT01222611
• Lead Sponsor: Fundacion SEIMC-GESIDA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Study Start: 2011-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAART inlcuding Fos APV/r	Fosamprenavir	ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir

Primary Outcome Measures

Name	Time	Method
HCV Viral load and changes in HCV protease gene	48 weeks	Undetectable HCV viral load. It will be considered that one patient achieves this endpoint if he/she has an undetectable HCV viral load (\<30 copies/mL) at any time during the study. If a patient shows undetectable HCV viral load and afterwards shows a detectable load, it will be considered that this patient achieved this endpoint.; Changes in the HCV protease gen. Any change from baseline in the protease catalytic domain, analysed by population sequencing of the catalytic domain of the HCV protease.

Trial Locations

Locations (6)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Príncipe de Asturias; 🇪🇸 Alcalá de Henares, Madrid, Spain

Hospital Doce de Octubre; 🇪🇸 Madrid, Spain