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

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

Study information

Study design	Open, multicentre of parallel groups
Primary study design	Interventional
Secondary study design	Multi-centre
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	CONTRA
Study objectives	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(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) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2006
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	364 patients (182 cases and 182 controls)
Key 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
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Spain

Study participating centre

C/Feixa Llarga s/n

Barcelona
8907
Spain

Sponsor information

Roche Farma S.A. (Spain)
Industry

C/Eucalipto 33.
Madrid
28016
Spain

Website	http://www.roche.es/
"ROR"	https://ror.org/04b8zcj45

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan