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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01222611

Acronym

FOSTER-C

Enrollment

Registered

2010-10-18

Start date

2011-03-31

Completion date

2013-06-30

Last updated

2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HIV Infection, HCV Coinfection

Keywords

HIV, HCV, HIV/HCV, Coinfection, Fosamprenavir

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.

Interventions

DRUGFosamprenavir

HAART including fosamprenavir boosted with ritonavir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026