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Open, multicenter, phase IV study to evaluate the safety and effectiveness of peginterferon alfa-2a (40 KD) associated with ribavirin for the treatment chronic hepatitis C with persistent normal ALT in HIV coinfected patients

Open, multicenter, phase IV study to evaluate the safety and effectiveness of peginterferon alfa-2a (40 KD) associated with ribavirin for the treatment chronic hepatitis C with persistent normal ALT in HIV coinfected patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001243-55-ES
Enrollment
230
Registered
2006-06-14
Start date
2006-07-07
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

Comparate the safety and effectivenes of the treatment with peginterferon alfa-2a in combination with ribavirin between HIV/HCV coinfected patients with persistent normal ALT levels versus HIV/HCV coinfected patients with high ALT levels

Interventions

Trade Name: Pegasys Product Name: Pegasys Pharmaceutical Form: Solution for injection INN or Proposed INN: peginterferón alfa-2a Concentration unit: µg/ml microgram(s)/millilitre Concentration type: e

Sponsors

Miguel Santin Cerezales
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: >18 years Serologic evidence of chronic hepatitis C Detectable RNA-HCV plasmatic levels Patients with at least 5 ALT determinations in the usual limits Serologic evidence of HIV-1 infection: Elisa and western-blot Stable status of HIV-1 infection. Stable HAART treatment patients unless 6 weeks before the basal evaluation No HAART therapy patients unless 6 weeks after the initiation of the study Negative pregnancy test 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: Child-Pugh>6 Previous or signs of decompensated hepatic disease DdI therapy Signs of chronic hepatic disease, not due to HCV Hepatocarcinome documented suspect Neutrophyles<1500 Haemoglobine<11 in women or <12 in men Platelets<70000 Severe Psiquiatric disease Evidence of alcohol or drugs consumption

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparate the safety and effectivenes of the treatment with peginterferon alfa-2a in combination with ribavirin between HIV/HCV coinfected patients with persistent normal ALT levels versus HIV/HCV coinfected patients with high ALT levels ;Secondary Objective: Knowing the hepatic histology in persistent normal ALT levels patients Value the hepatic histologic response in patients with sustained viral response Knowing the viral response in the 12th week depending on the basal ALT levels;Primary end point(s):—

Countries

Spain

Outcome results

None listed

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