Status:
COMPLETED
HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
Lead Sponsor:
Fundacion SEIMC-GESIDA
Collaborating Sponsors:
ViiV Healthcare
Conditions:
Chronic HIV Infection
HCV Coinfection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01222611
Start Date
March 1 2011
End Date
June 1 2013
Last Update
May 30 2014
Active Locations (6)
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1
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
2
Hospital Gregorio Marañón
Madrid, Madrid, Spain, 28007
3
Hospital La Paz
Madrid, Madrid, Spain, 28046
4
Hospital Clínico San Carlos
Madrid, Madrid, Spain