HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
NCT ID: NCT01222611
Last Updated: 2014-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2011-03-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard HAART
ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI
No interventions assigned to this group
HAART inlcuding Fos APV/r
ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir
Fosamprenavir
HAART including fosamprenavir boosted with ritonavir
Interventions
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Fosamprenavir
HAART including fosamprenavir boosted with ritonavir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Fundacion SEIMC-GESIDA
OTHER
Responsible Party
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Principal Investigators
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Juan Gonzalez, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital La Paz, Madrid (Spain)
Locations
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Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Doce de Octubre
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Countries
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Other Identifiers
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2010-023503-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GESIDA 6710
Identifier Type: -
Identifier Source: org_study_id