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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic HIV Infection, HCV Coinfection

Intervention / Treatment
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* Drug: Fosamprenavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard HAART<br>ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI | |
| Experimental: HAART inlcuding Fos APV/r<br>ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir | Drug: Fosamprenavir<br>* HAART including fosamprenavir boosted with ritonavir<br>* Other names: Telzir(r);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV Viral load and changes in HCV protease gene | 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. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HCV, HIV/HCV, Coinfection, Fosamprenavir