Open multicentre, phase IV study to evaluate efficacy and safety of pegylated interferon alpha-2a (40 KD) plus ribavirin for chronic hepatitis C with normal transaminases in human immunodeficiency virus-infected patients

ISRCTN ISRCTN01405766
DOI https://doi.org/10.1186/ISRCTN01405766
EudraCT/CTIS number 2006-001243-55
Secondary identifying numbers 2006-001243-55
Submission date
29/05/2007
Registration date
27/10/2008
Last edited
27/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Miguel Santin
Scientific

C/Feixa Llarga s/n
Barcelona
8907
Spain

+34 93 260 76 25
msantin@csub.scs.es

Study information

Study designOpen, multicentre of parallel groups
Primary study designInterventional
Secondary study designMulti-centre
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymCONTRA
Study objectivesResponse of chronic hepatitis C with normal transaminases to the combined treatment of pegylated interferon and ribavirin in human immunodeficiency virus (HIV)-infected patients is not lower than that achieved in patients with elevated levels of transaminases.
Ethics approval(s)The study was approved by the Reference Research Ethics Board of the IDIBELL, Hospital Universitari de Bellvitge on the 15th May 2006 (EudraCT no.: 2006-001243-55).
Health condition(s) or problem(s) studiedHuman immunodeficiency virus/hepatitis C virus (HIV-HCV) co-infection
InterventionCases and controls will be treated with the combination of pegylated interferon alpha-2a plus ribavirin for 48 weeks. Treatment will be stopped at week 12 if, at least, 2-log decrease or negativity is not achieved at week 12.

Management of patients during treatment and follow-up will be the same for patients and controls.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Pegylated interferon alpha-2a (40 KD), ribavirin
Primary outcome measureSustained virological response, defined as HCV-RNA less than 50 UI/mL 24 weeks after stopping treatment.
Secondary outcome measures1. Percentage of patients with normal ALT levels 24 weeks after stopping treatment
2. Percentage of patients with early virological response, defined as negativity or 2-log decrease at week 12 of treatment
Overall study start date01/05/2006
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants364 patients (182 cases and 182 controls)
Key inclusion criteriaCases:
1. HIV-infected patients
2. Older than 18 years
3. With chronic hepatitis C (positive serum hepatitis C virus-ribonucleic acid [HCV-RNA] and hepatitis C virus [HCV] antibody)
4. Persistent normal alanine aminotransferase (ALT)

Controls:
1. Adult HIV-infected patients
2. With chronic hepatitis C (positive serum HCV-RNA and HCV antibody)
3. Elevated ALT
4. Matched by sex, age, and HCV genotype
Key exclusion criteriaCases and controls:
1. Patients with hepatic cirrhosis Child B or C
2. CD4 counts less than 200 cells/mm^3
3. Autoimmune diseases or any contraindication for treatment with interferon or ribavirin
Date of first enrolment01/05/2006
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

C/Feixa Llarga s/n
Barcelona
8907
Spain

Sponsor information

Funders

Funder type

Industry

Roche Farma S.A. (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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