HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir (FOSTER-C)
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ClinicalTrials.gov Identifier: NCT01222611 |
Recruitment Status
:
Completed
First Posted
: October 18, 2010
Last Update Posted
: May 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic HIV Infection HCV Coinfection | Drug: Fosamprenavir | Phase 4 |
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 |

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
|
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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)
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- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222611
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 |
Principal Investigator: | Juan Gonzalez, MD | Hospital La Paz, Madrid (Spain) |
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 Key Record Dates |
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 |