Condition category
Infections and Infestations
Date applied
29/05/2007
Date assigned
27/10/2008
Last edited
27/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.roche.es/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes