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

HCV Coinfection Clinical Trial

— FOSTER-C  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222611
• Other study ID #: GESIDA 6710
• Secondary ID: 2010-023503-10
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2010
• Last updated: May 29, 2014
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Chronic HIV Infection
• Coinfection
• HCV Coinfection
• HIV Infections

Intervention

Drug:
• Fosamprenavir
HAART including fosamprenavir boosted with ritonavir

Locations

Country	Name	City	State
Spain	Hospital Príncipe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	ViiV Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 weeks	No