Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients

NCT ID: NCT00553930

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-05-31

Brief Summary

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.

Conditions

Hepatitis C, Chronic; HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G 2/3

Patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected.

Group Type: EXPERIMENTAL

Pegylated interferon alfa-2a and Ribavirin

Intervention Type: DRUG

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.

Pegylated interferon alfa 2a and Ribavirin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Pegasys; Copegus; Pegasis (TM); Copegus (TM)

Eligibility Criteria

Inclusion Criteria

• Age older than 18 years
• HIV infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis C virus (both anti-HCV antibodies and HCV RNA levels detectable in serum) not previously treated.
• Women of child-bearing age: negative pregnancy test
• Ability to understand and sign a written consent form

Exclusion Criteria

• Previous interferon treatment
• Pregnancy or breastfeeding
• Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA)
• Creatinine clearance < 50 ml/min, according to Cockcroft-Gault
• Decompensated liver disease
• History of organ transplantation
• Concomitant treatment with immunomodulators or didanosine
• Alcohol abuse or use of other recreational drugs
• History of severe psychiatric conditions
• Autoimmune diseases
• Inability to understand and sign a written consent form

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Andaluza de Enfermedades Infecciosas

NETWORK

Sponsor Role: lead

Responsible Party

Servicio Andaluz de Salud. Hospitales Universitarios Virgen del Rocio

Principal Investigators

Luis F Lopez-Cortes, MD, PhD

Role: STUDY_DIRECTOR

Infectious Disease Service. Hospitales Universitarios Virgen del Rocio. Sevilla. Spain

Antonio Rivero, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía. Córdoba. Spain

Mercedes Gonzalez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Victoria. Malaga. Spain

Angel Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Valme. Sevilla. Spain

Locations

Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio

Seville, Sevilla, Spain

Countries

Spain

References

Lopez-Cortes LF, Ruiz-Valderas R, Jimenez-Jimenez L, Gonzalez-Escribano MF, Torres-Cornejo A, Mata R, Rivero A, Pineda JA, Marquez-Solero M, Viciana P; Grupo para el Estudio de las Hepatitis Viricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas. Influence of IL28B polymorphisms on response to a lower-than-standard dose peg-IFN-alpha 2a for genotype 3 chronic hepatitis C in HIV-coinfected patients. PLoS One. 2012;7(1):e28115. doi: 10.1371/journal.pone.0028115. Epub 2012 Jan 3.

Reference Type: DERIVED

PMID: 22235243 (View on PubMed)

Other Identifiers

SAEI_IFN_1

Identifier Type: -

Identifier Source: org_study_id