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

Fundacion SEIMC-GESIDA42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic HIV Infection HCV Coinfection

Interventions

FosamprenavirDRUG

HAART including fosamprenavir boosted with ritonavir

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Hospital La Paz

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

HCV Viral load and changes in HCV protease gene

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.

Time frame: 48 weeks

Data from ClinicalTrials.gov

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