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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023503-10 | EudraCT Number |
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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard HAART | No Intervention | ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI | |
| HAART inlcuding Fos APV/r | Experimental | ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosamprenavir | Drug | HAART including fosamprenavir boosted with ritonavir |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV Viral load and changes in HCV protease gene | 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. | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Gonzalez, MD | Hospital La Paz, Madrid (Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Príncipe de Asturias | Alcalá de Henares | Madrid | Spain | |||
| Hospital Gregorio Marañón |
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| ID | Term |
|---|---|
| D060085 | Coinfection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C426859 | fosamprenavir |
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| Madrid |
| Madrid |
| 28007 |
| Spain |
| Hospital La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | Spain |
| Hospital Doce de Octubre | Madrid | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Madrid | Spain |