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 |
| Clinical Trials Information System (CTIS) | 2006-001243-55 |
| Protocol serial number | 2006-001243-55 |
| Sponsor | Roche Farma S.A. (Spain) |
| Funder | Roche Farma S.A. (Spain) |
- 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
Scientific
C/Feixa Llarga s/n
Barcelona
8907
Spain
| Phone | +34 93 260 76 25 |
|---|---|
| msantin@csub.scs.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open, multicentre of parallel groups |
| Secondary study design | Multi-centre |
| 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 |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pegylated interferon alpha-2a (40 KD), ribavirin |
| Primary outcome measure(s) |
Sustained virological response, defined as HCV-RNA less than 50 UI/mL 24 weeks after stopping treatment. |
| Key secondary outcome measure(s) |
1. Percentage of patients with normal ALT levels 24 weeks after stopping treatment |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 364 |
| 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
8907
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
