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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic HIV Infection Coinfection HCV Coinfection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fosamprenavir

Drug

HAART including fosamprenavir boosted with ritonavir

Other names: Telzir(r)

Primary outcomes

HCV Viral load and changes in HCV protease gene

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

ViiV Healthcare

Registry information

Official study title

Randomized, Controlled, Open Label, Pilot Study to Evaluate Fosamprenavir Activity on Genotype 1 Hepatitis C Virus (HCV) Infection Evolution in Human Immunodeficiency Virus (HIV) Co-infected Subjects With Antiretroviral Treatment Including Fosamprenavir

Acronym: FOSTER-C

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Oct 18, 2010
Registry last updated: May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed