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

This study is currently recruiting participants.
Verified June 2011 by Fundacion SEIMC-GESIDA
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01222611
First received: October 15, 2010
Last updated: March 7, 2013
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 72
Study Start Date: March 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222611

Contacts
Contact: Miriam Ramirez, BSc +34915568025 mramirez@f-sg.org
Contact: Herminia Esteban, BSc +34915568025 hesteban@f-sg.org

Locations
Spain
Hospital Príncipe de Asturias Recruiting
Alcalá de Henares, Madrid, Spain
Principal Investigator: Esperanza Casas, MD            
Hospital Gregorio Marañón Recruiting
Madrid, Spain, 28007
Principal Investigator: Juan Berenguer, MD            
Hospital Doce de Octubre Recruiting
Madrid, Spain
Principal Investigator: Federico Pulido, MD            
Principal Investigator: Rafael Rubio, MD            
Hospital Ramón y Cajal Recruiting
Madrid, Spain
Principal Investigator: Carmen Quereda, MD            
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Principal Investigator: Maria-Jesus Tellez, MD            
Hospital La Paz Recruiting
Madrid, Spain, 28046
Principal Investigator: Jose R Arribas, MD            
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
ViiV Healthcare
Investigators
Principal Investigator: Juan Gonzalez, MD Hospital La Paz, Madrid (Spain)
  More Information

No publications provided

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: March 7, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacion SEIMC-GESIDA:
HIV
HCV
HIV/HCV
Coinfection
Fosamprenavir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
 Hepatitis
Liver Diseases
Digestive System Diseases
Fosamprenavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013