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

Study Description

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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 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 or disease	Intervention/treatment	Phase
Chronic HIV Infection; HCV Coinfection	Drug: Fosamprenavir	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	March 2011
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Arms and Interventions

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Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. HCV Viral load and changes in HCV protease gene [ Time Frame: 48 weeks ]

   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:	NCT01222611 History of Changes
Other Study ID Numbers:	GESIDA 6710; 2010-023503-10 ( EudraCT Number )
First Posted:	October 18, 2010
Last Update Posted:	May 30, 2014
Last Verified:	September 2013

Keywords provided by Fundacion SEIMC-GESIDA:

HIV; HCV; HIV/HCV; Coinfection; Fosamprenavir

Additional relevant MeSH terms:

HIV Infections; Infection; Coinfection; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Parasitic Diseases	Ritonavir; Fosamprenavir; HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors