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
  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
Hepatitis C, Chronic
HIV Infections
Drug: Pegylated interferon alfa-2a and Ribavirin
Drug: Pegylated interferon alfa 2a and Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sociedad Andaluza de Enfermedades Infecciosas:

Primary Outcome Measures:
  • Sustained viral response(undetectable serum HCV-RNA) [ Time Frame: 24 weeks after the cessation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 71
Study Start Date: November 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G 2/3
Patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected.
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553930

Locations
Spain
Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio
Sevilla, Spain, 41013
Sponsors and Collaborators
Sociedad Andaluza de Enfermedades Infecciosas
Investigators
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

No publications provided by Sociedad Andaluza de Enfermedades Infecciosas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis F. Lopez-Cortes, Servicio Andaluz de Salud. Hospitales Universitarios Virgen del Rocio
ClinicalTrials.gov Identifier: NCT00553930     History of Changes
Other Study ID Numbers: SAEI_IFN_1
Study First Received: November 3, 2007
Last Updated: May 16, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:
HCV/HIV-coinfected patients
Peginterferon alfa-2a

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014