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

HIV Infections Clinical Trial

— SAEI_IFN_1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553930
• Other study ID #: SAEI_IFN_1
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2007
• Last updated: May 16, 2010
• Start date: November 2007
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Sociedad Andaluza de Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections

Intervention

Drug:
• Pegylated interferon alfa-2a and Ribavirin
All patients will be treated with the combination of pegIFN-a 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
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.

Locations

Country	Name	City	State
Spain	Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Andaluza de Enfermedades Infecciosas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained viral response(undetectable serum HCV-RNA)		24 weeks after the cessation of treatment	No
Secondary	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	No