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

NCT00553930 | Completed Phase 4 DMC

• 1 other identifier: SAEI_IFN_1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Keywords

HCV/HIV-coinfected patients; Peginterferon alfa-2a

Outcome Measures

Primary Outcomes (1)

• Sustained viral response(undetectable serum HCV-RNA)

  24 weeks after the cessation of treatment

Secondary Outcomes (1)

• 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.

  Throughout treatment and 24 weeks after finishing it

Study Arms (1)

G 2/3

EXPERIMENTAL

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; Drug: Pegylated interferon alfa 2a and Ribavirin

Interventions

Pegylated interferon alfa-2a and Ribavirin 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.

Also known as: Pegasys, Copegus

G 2/3

Pegylated interferon alfa 2a and Ribavirin 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.

Also known as: Pegasis (TM), Copegus (TM)

G 2/3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad Andaluza de Enfermedades Infecciosas: lead

Study Sites (1)

Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio

Seville, Sevilla, 41013, Spain

Location

Related Publications (1)

• 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.

  PMID: 22235243 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; HIV Infections

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Luis F Lopez-Cortes, MD, PhD

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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 3, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 18, 2010

Record last verified: 2010-05

Locations

ES (1)