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To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight).
To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week).
The PRESCO study (ribavirin dose 1000-1200 mg/day) emphasized that optimal ribavirin exposure seems to be crucial to maximize sustained virological response and minimize the incidence of relapses after treatment discontinuations.
Recent reports showed that it is beneficial to extend the treatment duration in patients without rapid virological response at 4 weeks (RNA-HCV < 50 UI/ml).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week |
|
| 2 | Active Comparator | Peginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ribavirin | Drug | 2000 mg/day |
| |
| ribavirin |
| Measure | Description | Time Frame |
|---|---|---|
| % patients with RNA-HCV < 50 UI/ml | 24 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| % patients with RNA-HCV < 50 UI/ml | 4 weeks on treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicente Soriano, Dr | Contact | +34914532500 | vsoriano@dragonet.es | |
| Pablo Barreiro, Dr | Contact | +34914532500 | pbarreiro@v4066.drago.net |
| Name | Affiliation | Role |
|---|---|---|
| Vicente Soriano, Dr | Hospital Carlos III. Madrid. Spain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Juan Canalejo | Not yet recruiting | A Coruña | A Coruña | 15006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20377423 | Derived | Vispo E, Labarga P, Guardiola JM, Barreiro P, Miralles C, Rubio R, Miralles P, Aguirrebengoa K, Portu J, Morello J, Rodriguez-Novoa S, Soriano V; PERICO Study Group. Preemptive erythropoietin plus high ribavirin doses to increase rapid virological responses in HIV patients treated for chronic hepatitis C. AIDS Res Hum Retroviruses. 2010 Apr;26(4):419-24. doi: 10.1089/aid.2009.0120. |
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| Drug |
1000-1200 mg/day |
|
| Peginterferon alfa-2a | Drug | Peginterferon alfa-2a 180 mcg/week |
|
| epoetin beta | Drug | epoetin beta 450 UI/week |
|
| Hospital Txagorritxu | Not yet recruiting | Vitoria-Gasteiz | Alava | 01009 | Spain |
|
| Hospital de Albacete | Not yet recruiting | Albacete | Albacete | 02006 | Spain |
|
| Hospital General de Elche | Not yet recruiting | Elche | Alicante | 03203 | Spain |
|
| Hospital Son Dureta | Not yet recruiting | Palma de Mallorca | Balearic Islands | 07014 | Spain |
|
| Hospital Santa Creu y Sant Pau | Recruiting | Barcelona | Barcelona | 08025 | Spain |
|
| Hospital Parc Taulí | Not yet recruiting | Sabadell | Barcelona | 08208 | Spain |
|
| Hospital General de Jerez de la Frontera | Not yet recruiting | Jerez de la Frontera | Cadiz | 11407 | Spain |
|
| Hospital Marqués de Valdecilla | Not yet recruiting | Santander | Cantabria | 39008 | Spain |
|
| Hospital General de Fuerteventura | Not yet recruiting | Puerto del Rosario | Fuerteventura | 35600 | Spain |
|
| Hospital Doctor Negrín | Not yet recruiting | Las Palmas de Gran Canarias | Gran Canaria | 35020 | Spain |
|
| Hospital Clínico san Cecilio | Not yet recruiting | Granada | Granada | 18012 | Spain |
|
| Hospital San Jorge | Not yet recruiting | Huesca | Huesca | 22004 | Spain |
|
| Hospital Arquitecto Marcide | Not yet recruiting | Ferrol | La Coruña | 15405 | Spain |
|
| Hospital Clínico Universitario | Not yet recruiting | Santiago | La Coruña | 15706 | Spain |
|
| Hospital Xeral-Caldé | Not yet recruiting | Lugo | Lugo | 27004 | Spain |
|
| Hospital de Alcorcon | Not yet recruiting | Alcorcón | Madrid | 28922 | Spain |
|
| Hospital Severo Ochoa | Not yet recruiting | Leganés | Madrid | 28911 | Spain |
|
| Hospital de la Princesa | Not yet recruiting | Madrid | Madrid | 28006 | Spain |
|
| Hospital Gregorio Marañón | Not yet recruiting | Madrid | Madrid | 28007 | Spain |
|
| Hospital Carlos III | Recruiting | Madrid | Madrid | 28029 | Spain |
|
| Hospital Clínico San Carlos | Not yet recruiting | Madrid | Madrid | 28040 | Spain |
|
| Hospital 12 de Octubre | Not yet recruiting | Madrid | Madrid | 28041 | Spain |
|
| Hospital Santa Maria del Rosell | Not yet recruiting | Murcia | Murcia | 30203 | Spain |
|
| Hospital Clínico Virgen de la Victoria | Recruiting | Málaga | Málaga | 29010 | Spain |
|
| Hospital Xeral-Cíes | Recruiting | Vigo | Pontevedra | 36204 | Spain |
|
| Hospital do Meixoeiro | Not yet recruiting | Vigo | Pontevedra | 36214 | Spain |
|
| Hospital Central de Asturias | Not yet recruiting | Oviedo | Principality of Asturias | 33006 | Spain |
|
| Hospital Clínico de Salamanca | Not yet recruiting | Salamanca | Salamanca | 37007 | Spain |
|
| Hospital General de la Palma | Not yet recruiting | La Palma | Santa Cruz de Tenerife | 38713 | Spain |
|
| Hospital Universitario de Canarias | Not yet recruiting | San Cristóbal de La Laguna | Santa Cruz de Tenerife | 38320 | Spain |
|
| Hospital de la Candelaria | Not yet recruiting | Santa Cruz de Tenerife | Santa Cruz de Tenerife | 38010 | Spain |
|
| Hospital Virgen de la Macarena | Not yet recruiting | Seville | Sevilla | 41009 | Spain |
|
| Hospital de Valme | Not yet recruiting | Seville | Sevilla | 41014 | Spain |
|
| Hospital Universitario la Fé | Not yet recruiting | Valencia | Valencia | 46009 | Spain |
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| Hospial Clinico Universitario de Valencia | Not yet recruiting | Valencia | Valencia | 46010 | Spain |
|
| Hospital Clínico de Valladolid | Not yet recruiting | Valladolid | Valladolid | 47011 | Spain |
|
| Hospital de Cruces | Recruiting | Barakaldo | Vizcaya | 48913 | Spain |
|
| Hospital Clínico Universitario Lozano Blesa | Not yet recruiting | Zaragoza | Zaragoza | 50009 | Spain |
|
| Hospital Miguel Servet | Not yet recruiting | Zaragoza | Zaragoza | 50009 | Spain |
|
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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