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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004948-45 |
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A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.
The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.
In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.
The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.
Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.
To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in combination with ribavirin have RNA-HCV undetectable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks |
|
| 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a + ribavirin | Drug | Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with RNA-HCV undetectable | at 48 week of study (24 weeks after the end of treatment period of trial). |
| Measure | Description | Time Frame |
|---|---|---|
| % of percentage of patients with RNA-HCV undetectable | 24 weeks of trial period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Hernández-Quero, Dr | Hospital Clínico Universitario San Cecilio | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Txagorritxu | Vitoria-Gasteiz | Alava | 01009 | Spain | ||
| Hospital Santa Creu i Sant Pau |
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| Barcelona |
| Barcelona |
| 08025 |
| Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Puerta del Mar | Cadiz | Cádiz | 11009 | Spain |
| Hospital de Jerez | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital Insular | Las Palmas | Gran Canaria | 35016 | Spain |
| Hospital Clínico Universitario San Cecilio | Granada | Granada | 18013 | Spain |
| Hospital de Donostia | San Sebastián | Guipúzcoa | 20014 | Spain |
| Complejo Hospitalario Universitario | Santiago | La Coruña | 15705 | Spain |
| Fundación Hospital de Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Son Dureta | Palma de Mallorca | Mallorca | 07014 | Spain |
| Hospital Virgen Macarena | Seville | Sevilla | 41008 | Spain |
| Hospital Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| Hospital de Valme | Seville | Sevilla | 41014 | Spain |
| Consorcio Hospital General | Valencia | Valencia | 46014 | Spain |
| Hospital Clínico de Valladolid | Valladolid | Valladolid | 47011 | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| D060085 | Coinfection |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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