Clinical trial NCT00221650: Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients
Official title: Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Hepatitis C, Chronic
Treatment Failure
Keywords: Hepatitis C, Chronic
HCV infection
HIV infection
Treatment Failure
PEG interferon
Interferons/therapeutic use
Interferon Alfa-2a/adverse effects
Ribavirin/therapeutic use
Ribavirin/adverse effects
Drug Therapy, Combination
Treatment Experienced
Treatment Naive
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level
* HIV infection (CD4\>250/µL, HIV RNA\<10 000 copies/ml) treated or not with antiretroviral therapy
* Signed informed consent

Exclusion Criteria:

* Chronic hepatitis B
* Alcohol consumption\>40g/day
* Evidence of decompensated liver disease
* Hepatocellular carcinoma
* Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease

Primary outcomes:
measure: Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level
timeFrame: 24 weeks after the end of anti-HCV treatment
Secondary outcomes:
measure: Proportion of patients with a virological response
timeFrame: at weeks 24 and 48
measure: Safety of treatment
measure: Influence of anti-HCV treatment on CD4 count and HIV RNA
measure: Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD
Study officials:
affiliation: Hôpital Pellegrin, 33076 Bordeaux Cedex, France
name: Didier Neau, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Genevieve Chene, Pr
role: STUDY_CHAIR
References:
citation: Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38. doi: 10.1186/1471-2288-6-38.