HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir (FOSTER-C)
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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.
Condition | Intervention | Phase |
---|---|---|
Chronic HIV Infection HCV Coinfection |
Drug: Fosamprenavir |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- HCV Viral load and changes in HCV protease gene [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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.
Estimated Enrollment: | 72 |
Study Start Date: | March 2011 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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)
|
![](https://webarchive.library.unt.edu/web/20130305100108im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130305100108im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Manuel Cotarelo, PhD | +34915568025 | mcotarelo@f-sg.org |
Contact: Herminia Esteban, BSc | +34915568025 | hesteban@f-sg.org |
Spain | |
Hospital Príncipe de Asturias | Recruiting |
Alcalá de Henares, Madrid, Spain | |
Principal Investigator: Esperanza Casas, MD | |
Hospital Gregorio Marañón | Recruiting |
Madrid, Spain, 28007 | |
Principal Investigator: Juan Berenguer, MD | |
Hospital Doce de Octubre | Recruiting |
Madrid, Spain | |
Principal Investigator: Federico Pulido, MD | |
Principal Investigator: Rafael Rubio, MD | |
Hospital Ramón y Cajal | Recruiting |
Madrid, Spain | |
Principal Investigator: Carmen Quereda, MD | |
Hospital Clínico San Carlos | Recruiting |
Madrid, Spain | |
Principal Investigator: Maria-Jesus Tellez, MD | |
Hospital La Paz | Recruiting |
Madrid, Spain, 28046 | |
Principal Investigator: Jose R Arribas, MD |
Principal Investigator: | Juan Gonzalez, MD | Hospital La Paz, Madrid (Spain) |
![](https://webarchive.library.unt.edu/web/20130305100108im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Dr Juan Gonzalez-Garcia, Hospital La Paz |
ClinicalTrials.gov Identifier: | NCT01222611 History of Changes |
Other Study ID Numbers: | GESIDA 6710, 2010-023503-10 |
Study First Received: | October 15, 2010 |
Last Updated: | June 14, 2011 |
Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Fundacion SEIMC-GESIDA:
HIV HCV HIV/HCV Coinfection Fosamprenavir |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Hepatitis, Viral, Human Flaviviridae Infections |
Hepatitis Liver Diseases Digestive System Diseases Fosamprenavir Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 03, 2013