- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01684787
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Barcelona, Spain, 08003
- Hospital del Mar
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Barcelona, Spain, 08036
- Hospital Clínic
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Barcelona, Spain, 08025
- Hospital Santa Creu i Sant Pau
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Huesca, Spain, 22004
- Hospital San Jorge
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Madrid, Spain, 28040
- Hospital Clinico San Carlos
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Madrid, Spain, 28034
- Hospital Ramon y Cajal
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Madrid, Spain, 28041
- Hospital 12 de Octubre
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Madrid, Spain, 28006
- Hospital de La Princesa
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Tarragona, Spain, 43007
- Hospital Joan XXIII
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Zaragoza, Spain, 50009
- Hospital Clinico Lozano Blesa
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Alava
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Vitoria, Alava, Spain, 01009
- Hospital de Txagorritxu
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Barcelona
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Hospitalet, Barcelona, Spain, 08907
- Consorci Sanitari Integral
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Hospitalet, Barcelona, Spain, 08907
- Hospital Universitari of Bellvitge
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Mataró, Barcelona, Spain, 08304
- Hospital General de Mataró
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Terrassa, Barcelona, Spain, 08227
- Consorci Sanitari de Terrassa
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Guipúzcoa
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San Sebastián, Guipúzcoa, Spain, 20014
- Hospital de Donostia
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Pontevedra
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Vigo, Pontevedra, Spain, 36204
- Hospital Xeral-Cíes
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Vizcaya
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Baracaldo, Vizcaya, Spain, 48903
- Hospital de Cruces
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the inclusion
- Negative contraception test
- Informed consent signed
Exclusion Criteria:
- Pregnancy
- Any previous treatment for CHC
- Any experimental treatment in the 6 previous weeks to the inclusion
- Cirrhosis grade B or C (Child-Pugh)
- Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, …
- Hepatic cancer
- Neutrophils < 1500 cel/mL, Platelets < 70000 cel/mL, Hemoglobin < 11 g/dL (men) or < 12 g/dL (women) previous to inclusion
- Severe psychiatric illness background
- Serum creatinin > 1,5 times the upper normal limit
- Background of Pulmonary or Cardiovascular disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Peginterferon alfa-2a + ribavirin in normal ALT
|
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other Names:
|
Active Comparator: 2
peginterferon alfa-2a + ribavirin in elevated ALT
|
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
% patients with RNA-HCV negative
Time Frame: 24 weeks after treatment
|
24 weeks after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Miguel Santin, Dr, Hospital Universitari of Bellvitge
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Immunologic Factors
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
Other Study ID Numbers
- Miguel Santín
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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