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

May 29, 2014 updated by: Fundacion SEIMC-GESIDA

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

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 Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Clínico San Carlos
    • Madrid
      • Alcalá de Henares, Madrid, Spain
        • Hospital Principe de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard HAART
ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI
Experimental: HAART inlcuding Fos APV/r
ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir
HAART including fosamprenavir boosted with ritonavir
Other Names:
  • Telzir(r)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Juan Gonzalez, MD, Hospital La Paz, Madrid (Spain)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 15, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

May 30, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

September 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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