Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients (SAEI_IFN_1)

This study has been completed.
Sponsor:
Information provided by:
Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT00553930
First received: November 3, 2007
Last updated: May 16, 2010
Last verified: May 2010

November 3, 2007
May 16, 2010
November 2007
May 2010   (final data collection date for primary outcome measure)
Sustained viral response(undetectable serum HCV-RNA) [ Time Frame: 24 weeks after the cessation of treatment ] [ Designated as safety issue: No ]
Sustained viral response(undetectable serum HCV-RNA) [ Time Frame: 24 weeks after the cessation of treatment ]
Complete list of historical versions of study NCT00553930 on ClinicalTrials.gov Archive Site
Relationships between the plasma interferon an ribavirin concentrations and efficacy. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. [ Time Frame: Throughout treatment and 24 weeks after finishing it ] [ Designated as safety issue: No ]
Relationships between the plasma interferon an ribavirin concentrations and efficacy. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. [ Time Frame: Throughout treatment and 24 weeks after finishing it ]
Not Provided
Not Provided
 
Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C, Chronic
  • HIV Infections
  • 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.
    Other Names:
    • Pegasys
    • Copegus
  • 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.
    Other Names:
    • Pegasis (TM)
    • Copegus (TM)
Experimental: G 2/3
Patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected.
Interventions:
  • Drug: Pegylated interferon alfa-2a and Ribavirin
  • Drug: Pegylated interferon alfa 2a and Ribavirin
López-Cortés LF, Ruiz-Valderas R, Jimenez-Jimenez L, González-Escribano MF, Torres-Cornejo A, Mata R, Rivero A, Pineda JA, Marquez-Solero M, Viciana P; Grupo para el Estudio de las Hepatitis Víricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas. Influence of IL28B polymorphisms on response to a lower-than-standard dose peg-IFN-α 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00553930
SAEI_IFN_1
Yes
Luis F. Lopez-Cortes, Servicio Andaluz de Salud. Hospitales Universitarios Virgen del Rocio
Sociedad Andaluza de Enfermedades Infecciosas
Not Provided
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
Sociedad Andaluza de Enfermedades Infecciosas
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP