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

Primary Purpose

Chronic HIV Infection, HCV Coinfection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Fosamprenavir
Sponsored by
Fundacion SEIMC-GESIDA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic HIV Infection focused on measuring HIV, HCV, HIV/HCV, Coinfection, Fosamprenavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Príncipe de Asturias
  • Hospital Gregorio Marañón
  • Hospital La Paz
  • Hospital Clínico San Carlos
  • Hospital Doce de Octubre
  • Hospital Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard HAART

HAART inlcuding Fos APV/r

Arm Description

ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI

ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2010
Last Updated
May 29, 2014
Sponsor
Fundacion SEIMC-GESIDA
Collaborators
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01222611
Brief Title
HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion SEIMC-GESIDA
Collaborators
ViiV Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HIV Infection, HCV Coinfection
Keywords
HIV, HCV, HIV/HCV, Coinfection, Fosamprenavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard HAART
Arm Type
No Intervention
Arm Description
ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI
Arm Title
HAART inlcuding Fos APV/r
Arm Type
Experimental
Arm Description
ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir
Intervention Type
Drug
Intervention Name(s)
Fosamprenavir
Other Intervention Name(s)
Telzir(r)
Intervention Description
HAART including fosamprenavir boosted with ritonavir
Primary Outcome Measure Information:
Title
HCV Viral load and changes in HCV protease gene
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Gonzalez, MD
Organizational Affiliation
Hospital La Paz, Madrid (Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Príncipe de Asturias
City
Alcalá de Henares
State/Province
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain

12. IPD Sharing Statement

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

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