Contact information
Type
Scientific
Primary contact
Dr Miguel Santin
ORCID ID
Contact details
C/Feixa Llarga s/n
Barcelona
8907
Spain
+34 93 260 76 25
msantin@csub.scs.es
Additional identifiers
EudraCT number
2006-001243-55
ClinicalTrials.gov number
Protocol/serial number
2006-001243-55
Study information
Scientific title
Acronym
CONTRA
Study hypothesis
Response 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
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).
Study design
Open, multicentre of parallel groups
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Human immunodeficiency virus/hepatitis C virus (HIV-HCV) co-infection
Intervention
Cases 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 type
Drug
Phase
Phase IV
Drug names
Pegylated interferon alpha-2a (40 KD), ribavirin
Primary outcome measure
Sustained virological response, defined as HCV-RNA less than 50 UI/mL 24 weeks after stopping treatment.
Secondary outcome measures
1. 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 trial start date
01/05/2006
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Cases:
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
364 patients (182 cases and 182 controls)
Participant exclusion criteria
Cases 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
Recruitment start date
01/05/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Spain
Trial participating centre
C/Feixa Llarga s/n
Barcelona
8907
Spain
Sponsor information
Organisation
Roche Farma S.A. (Spain)
Sponsor details
C/Eucalipto 33.
Madrid
28016
Spain
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Roche Farma S.A. (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list