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

This study has been completed.
Sponsor:
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
  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:


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.



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

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
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 Clínico San Carlos
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital La Paz
Madrid, Spain, 28046
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

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: May 29, 2014
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
Coinfection
Communicable Diseases
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Parasitic Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Fosamprenavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014