Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
CONTRA
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
1 other identifier
interventional
80
1 country
18
Brief Summary
In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis. Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients. The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT. In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different. In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment. This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients. The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2006
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2012
CompletedSeptember 13, 2012
September 1, 2012
4.7 years
June 11, 2010
September 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% patients with RNA-HCV negative
24 weeks after treatment
Study Arms (2)
1
EXPERIMENTALPeginterferon alfa-2a + ribavirin in normal ALT
2
ACTIVE COMPARATORpeginterferon alfa-2a + ribavirin in elevated ALT
Interventions
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Eligibility Criteria
You may qualify if:
- Patients over 18 years old
- Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of ALT (CONTROL)
- CD4 \> 200 cel/mL
- Negative contraception test
- Informed consent signed
You may not qualify if:
- Pregnancy
- Any previous treatment for CHC
- Cirrhosis grade B or C (Child-Pugh)
- Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, …
- Hepatic cancer
- Severe psychiatric illness background
- Serum creatinin \> 1,5 times the upper normal limit
- Background of Pulmonary or Cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Miguel Santinlead
Study Sites (18)
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Clinic
Barcelona, Barcelona, 08036, Spain
Consorci Sanitari Integral
Hospitalet, Barcelona, 08907, Spain
Hospital Universitari of Bellvitge
Hospitalet, Barcelona, 08907, Spain
Hospital General de Mataró
Mataró, Barcelona, 08304, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, 20014, Spain
Hospital San Jorge
Huesca, Huesca, 22004, Spain
Hospital de la Princesa
Madrid, Madrid, 28006, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Xeral-Cíes
Vigo, Pontevedra, 36204, Spain
Hospital Joan XXIII
Tarragona, Tarragona, 43007, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miguel Santin, Dr
Hospital Universitari of Bellvitge
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 11, 2010
First Posted
September 13, 2012
Study Start
September 1, 2006
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
September 13, 2012
Record last verified: 2012-09