Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Fundacion SEIMC-GESIDA

Collaborator
ViiV Healthcare

Information provided by (Responsible Party)
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier
NCT01222611

First received: October 15, 2010
Last updated: May 29, 2014
Last Verified: September 2013
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Chronic HIV Infection
HCV Coinfection

Drug : Fosamprenavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures

  • 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.

Enrollment: 42
Study Start Date: March 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
Drug: Fosamprenavir

HAART including fosamprenavir boosted with ritonavir

Other Name: Telzir(r)
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222611

Locations

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

Sponsors and Collaborators

Fundacion SEIMC-GESIDA
ViiV Healthcare

Investigators

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

More Information


Responsible Party: Fundacion SEIMC-GESIDA  
ClinicalTrials.gov Identifier: NCT01222611   History of Changes  
Other Study ID Numbers: GESIDA 6710  
  2010-023503-10  
Study First Received: October 15, 2010  
Last Updated: May 29, 2014  

Keywords provided by Fundacion SEIMC-GESIDA:

HIV
HCV
HIV/HCV
Coinfection
Fosamprenavir

Additional relevant MeSH terms:
Infection
HIV Infections
Coinfection
Ritonavir
Fosamprenavir

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.