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| Sponsored by: |
Sociedad Andaluza de Enfermedades Infecciosas |
| Information provided by: | Sociedad Andaluza de Enfermedades Infecciosas |
| ClinicalTrials.gov Identifier: | NCT00553930 |
Purpose
Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.
Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected patients in real use conditions.
Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud will be enrolled. The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point wall be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
| Condition | Intervention | Phase |
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Hepatitis C, Chronic HIV Infections |
Drug: Pegylated interferon alfa-2a and Ribavirin Drug: Pegylated interferon alfa 2a and Ribavirin |
Phase IV |
| MedlinePlus related topics: | AIDS Hepatitis Hepatitis C |
| ChemIDplus related topics: | Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons BaseLine |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Efficacy of Low Dose Pegylated Interferon-α 2a Plus Ribavirin for the Treatment of Chronic Hepatitis C, Genotypes 2 or 3, in HIV-Coinfected Patients. |
| Estimated Enrollment: | 71 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|
G 2/3: Experimental
Patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected.
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Drug: Pegylated interferon alfa-2a and Ribavirin
All patients will be treated with the combination of pegIFN-α 2a (135 μg per week)plus oral Ribavirin at a dose of 800 mg per day. The treatment will be continued up to 20 weeks after reaching an undetectable plasma RNA-HCV. Treatment will be discontinued for patients who did not achieve a reduction of al least 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 and will be considered as viral failures.
Drug: Pegylated interferon alfa 2a and Ribavirin
Pegylated interferon alfa 2a (135 ug/week)and Ribavirin (800 mg/day). Duration: 20 weeks after reaching an undetectable plasma RNA_HCV. Treatment will be discontinued for patients who did not achieve a decrease of >= 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 of treatment or earlier and will be considered as viral failures.
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Luis F Lopez-Cortes, MD, PhD | 34 - 955013096 | lflopez@telefonica.net |
| Spain | |||||
| Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio | Recruiting | ||||
| Sevilla, Spain, 41013 | |||||
| Principal Investigator: Luis F Lopez-Cortes, MD, PhD | |||||
| Sociedad Andaluza de Enfermedades Infecciosas |
| Study Director: | Luis F Lopez-Cortes, MD, PhD | Infectious Disease Service. Hospitales Universitarios Virgen del Rocio. Sevilla. Spain |
| Principal Investigator: | Antonio Rivero, MD, PhD | Hospital Universitario Reina Sofía. Córdoba. Spain |
| Principal Investigator: | Mercedes Gonzalez, MD, PhD | Hospital Universitario Virgen de la Victoria. Malaga. Spain |
| Principal Investigator: | Angel Garcia, MD | Hospital Universitario de Valme. Sevilla. Spain |
More Information
| Study ID Numbers: | SAEI_IFN_1 |
| First Received: | November 3, 2007 |
| Last Updated: | December 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00553930 |
| Health Authority: | Spain: Spanish Agency of Medicines |
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