Clinical trial NCT00553930: Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
HIV Infections
Keywords: HCV/HIV-coinfected patients
Peginterferon alfa-2a
Lead sponsor: Sociedad Andaluza de Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2007-11-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sustained viral response(undetectable serum HCV-RNA)
timeFrame: 24 weeks after the cessation of treatment
Secondary outcomes:
measure: 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.
timeFrame: Throughout treatment and 24 weeks after finishing it
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio
Study officials:
affiliation: Infectious Disease Service. Hospitales Universitarios Virgen del Rocio. Sevilla. Spain
name: Luis F Lopez-Cortes, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Reina Sofía. Córdoba. Spain
name: Antonio Rivero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen de la Victoria. Malaga. Spain
name: Mercedes Gonzalez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Valme. Sevilla. Spain
name: Angel Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.