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Sponsored by: |
Hospital Carlos III, Madrid |
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Information provided by: | Hospital Carlos III, Madrid |
ClinicalTrials.gov Identifier: | NCT00530972 |
To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who has relapser after treatment with previous therapies based in Interferon.
Condition | Intervention | Phase |
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Chronic Hepatitis C HIV Infections |
Drug: Peginterferon alfa-2a |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Treatment of Patients With Chronic Hepatitis C co-Infected With HIV Relapsers After Treatment With Previous Therapies: Open, Pilot Trial |
Estimated Enrollment: | 150 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2008 |
An important number of co-infected patients were treated suboptimally in the past with others ineffective therapies interferon-based.
All co-infected patients should be an opportunity of retreatment with actually therapies.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hgb >/= 12 g/dL in women or 13 g/dL in men Leucocytes >/= 3000 mm3 Neutrophil count (ANC) >/= 1500 cells/mm3 Platelet count >/= 100.000 cells/mm3 Normal prothrombin, bilirubin, albumin, creatinine and uric acid
Exclusion Criteria:
Contact: Vicente Soriano, Dr | +34914532536 | vsoriano@dragonet.es |
Contact: Pablo Barreiro, Dr | +34914532500 | pbarreiro@v4066.drago.net |
Spain, Madrid | |
Hospital Carlos III | Recruiting |
Madrid., Madrid, Spain, 28029 | |
Contact: Vicente Soriano, Dr +34914532536 vsoriano@dragonet.es | |
Contact: Pablo Barreiro, Dr +34914532500 pbarreiro@v4066.drago.net | |
Principal Investigator: Vicente Soriano, Dr | |
Sub-Investigator: Pablo Barreiro, Dr | |
Sub-Investigator: Pablo Labarga, Dr | |
Sub-Investigator: Luz Martín-Carbonero, Dr | |
Sub-Investigator: Javier García-Samaniego, Dr | |
Sub-Investigator: Sonia Rodríguez-Novoa, Dr | |
Sub-Investigator: Eugenia Vispo, Dr |
Principal Investigator: | Vicente Soriano, Dr | Hospital Carlos III. Madrid. Spain |
Study ID Numbers: | 2005-001192-34 |
Study First Received: | September 17, 2007 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00530972 |
Health Authority: | Spain: Spanish Agency of Medicines |
co-infected HCV/HIV relapsers |
Sexually Transmitted Diseases, Viral Liver Diseases Hepatitis, Chronic Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases |
Digestive System Diseases HIV Infections Sexually Transmitted Diseases Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Flaviviridae Infections Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |