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

October 15, 2010
May 29, 2014
March 2011
June 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01222611 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic HIV Infection
  • HCV Coinfection
Drug: Fosamprenavir
HAART including fosamprenavir boosted with ritonavir
Other Name: Telzir(r)
  • 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
    Intervention: Drug: Fosamprenavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01222611
GESIDA 6710, 2010-023503-10
Yes
Fundacion SEIMC-GESIDA
Fundacion SEIMC-GESIDA
ViiV Healthcare
Principal Investigator: Juan Gonzalez, MD Hospital La Paz, Madrid (Spain)
Fundacion SEIMC-GESIDA
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP