HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
Information source: Fundacion SEIMC-GESIDA
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic HIV Infection; HCV Coinfection
Intervention: Fosamprenavir (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Fundacion SEIMC-GESIDA Official(s) and/or principal investigator(s):
Juan Gonzalez, MD, Principal Investigator, Affiliation: Hospital La Paz, Madrid (Spain)
Overall contact:
Manuel Cotarelo, PhD, Phone: +34915568025, Email: mcotarelo@f-sg.org
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: HCV Viral load and changes in HCV protease gene
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Manuel Cotarelo, PhD, Phone: +34915568025, Email: mcotarelo@f-sg.org
Hospital Gregorio Marañón, Madrid 28007, Spain; Recruiting
Juan Berenguer, MD, Principal Investigator
Hospital Doce de Octubre, Madrid, Spain; Recruiting
Federico Pulido, MD, Principal Investigator
Rafael Rubio, MD, Principal Investigator
Hospital La Paz, Madrid 28046, Spain; Recruiting
Jose R Arribas, MD, Principal Investigator
Hospital Clínico San Carlos, Madrid, Spain; Recruiting
Maria-Jesus Tellez, MD, Principal Investigator
Hospital Ramón y Cajal, Madrid, Spain; Recruiting
Carmen Quereda, MD, Principal Investigator
Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain; Recruiting
Esperanza Casas, MD, Principal Investigator
Additional Information
Starting date: March 2011
Last updated: June 14, 2011
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