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Open, multicenter and randomized study phase IV to evaluate the efficacy and safety of 24 weeks more of treatment in patients with chronic hepatitis C genotype 1 and/or 4 co-infected with human inmmunodeficiency virus - Treatment of co-infected HIV/HCV patients genotype 1/4 24 weeks more than standar duration

Open, multicenter and randomized study phase IV to evaluate the efficacy and safety of 24 weeks more of treatment in patients with chronic hepatitis C genotype 1 and/or 4 co-infected with human inmmunodeficiency virus - Treatment of co-infected HIV/HCV patients genotype 1/4 24 weeks more than standar duration

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004948-45-ES
Enrollment
Unknown
Registered
2006-05-24
Start date
2005-05-08
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C

Interventions

Trade Name: Pegasys 180 mcg Product Name: Peginterferón alfa-2a Product Code: EU/1/02/221/008 Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGINTERFERON ALFA 2-a Concentration unit

Sponsors

José Hernández-Quero. Hospital Clínico San Cecilio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients in treatment with peginterferon alfa-2a and ribavirin which HCV-RNA is undetectable at 48 weeks. - Patients with RNA-HCV positive and genotype 1/4 at 44 weeks before the start of study. - HIV positive - AIDS stable - Pregnancy test negative - Patient authorization to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with HCV-RNA positive after 44 weeks of treatment with peginterferon alfa-2a in combination with ribavirin - Patients with other different treatment to the study. - 3 o more weeks without treatment between the end of the standard treatment and the inclusion in the trial.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy to long on 24 weeks more than standard duration of treatment with peginterferon alfa-2a in combination with ribavirin in patients co-infected HIV/HCV genotype 1/4.;Secondary Objective: To evaluate the safety;Primary end point(s): Percentage of patients with HCV-RNA undetectable at 48 week of the study (24 weeks before the end of the study treatment)—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026