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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000203-34 |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.
Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment.
In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%.
In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks.
In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.
Patients will randomized to receive 180 µg/weekly of Pef interferon alpha-2a and 800 mg/daily of Ribavirin during 24 weeks or 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 24 weeks |
|
| 2 | Active Comparator | Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg interferon + Ribavirin | Drug | Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with RNA-HCV undetectable 24 weeks | 24 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients at the end of treatment | 48 weeks of treatmemt |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Ortega, Dr | Hospital General Universitario de Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Alicante | Alicante | Alicante | 03010 | Spain | ||
| Hospital de Elche |
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| Peg interferon + Ribavirin | Drug | Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks |
|
|
| Elche |
| Alicante |
| 03202 |
| Spain |
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08915 | Spain |
| Hospital del Mar | Barcelona | Barcelona | 08003 | Spain |
| Hospital General de Castellón | Castellon | Castellón | 12004 | Spain |
| Hospital de Jerez | Jerez de la Frontera | Cádiz | 11009 | Spain |
| Hospital Clínico San Cecilio | Granada | Granada | 18013 | Spain |
| Hospital Infanta Elena | Huelva | Huelva | 21004 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital la Paz | Madrid | Madrid | 28046 | Spain |
| Hospital General de Murcia | Murcia | Murcia | 3003 | Spain |
| Hospital Carlos Haya | Málaga | Málaga | 29010 | Spain |
| Hospital Xeral-Cíes | Vigo | Pontevedra | 36204 | Spain |
| Hospital Virgen Macarena | Seville | Sevilla | 41008 | Spain |
| Hospital de Gandia | Gandia | Valencia | 46700 | Spain |
| Hospital la Fe | Valencia | Valencia | 46009 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| Hospital Arnau de Vilanova | Valencia | Valencia | 46015 | Spain |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006505 | Hepatitis |
| D060085 | Coinfection |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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