NCT00221650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

September 13, 2005

Last Update Submit

June 12, 2007

Conditions

HIV InfectionsHepatitis C, ChronicTreatment Failure

Keywords

Hepatitis C, ChronicHCV infectionHIV infectionTreatment FailurePEG interferonInterferons/therapeutic useInterferon Alfa-2a/adverse effectsRibavirin/therapeutic useRibavirin/adverse effectsDrug Therapy, CombinationTreatment ExperiencedTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level

    24 weeks after the end of anti-HCV treatment

Secondary Outcomes (4)

  • Proportion of patients with a virological response

    at weeks 24 and 48

  • Safety of treatment

  • Influence of anti-HCV treatment on CD4 count and HIV RNA

  • Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment

Interventions

Peginterferon alfa2aDRUG
RibavirinDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD

Bordeaux, 33076, France

Location

Related Publications (1)

  • 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.

    PMID: 16879756BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHepatitis C, ChronicHepatitis C

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Didier Neau, MD-PhD

    Hôpital Pellegrin, 33076 Bordeaux Cedex, France

    PRINCIPAL INVESTIGATOR

  • Genevieve Chene, Pr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

April 1, 2002

Study Completion

June 1, 2004

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations

FR(1)