HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir (FOSTER-C)
This study has been completed.
Sponsor:
Fundacion SEIMC-GESIDA
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01222611
First received: October 15, 2010
Last updated: May 29, 2014
Last verified: September 2013
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Purpose
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 |
Resource links provided by NLM:
Further study details as provided by Fundacion SEIMC-GESIDA:
Primary Outcome Measures:
- 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.
| Enrollment: | 42 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2013 (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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222611
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222611
Locations
| Spain | |
| Hospital Príncipe de Asturias | |
| Alcalá de Henares, Madrid, Spain | |
| Hospital Clínico San Carlos | |
| Madrid, Spain | |
| Hospital Doce de Octubre | |
| Madrid, Spain | |
| Hospital Gregorio Marañón | |
| Madrid, Spain, 28007 | |
| Hospital La Paz | |
| Madrid, Spain, 28046 | |
| 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
No publications provided
| Responsible Party: | Fundacion SEIMC-GESIDA |
| ClinicalTrials.gov Identifier: | NCT01222611 History of Changes |
| Other Study ID Numbers: | GESIDA 6710, 2010-023503-10 |
| Study First Received: | October 15, 2010 |
| Last Updated: | May 29, 2014 |
| 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:
|
Fosamprenavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors |
HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015