Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients (CONTRA)

September 12, 2012 updated by: Miguel Santin, Miguel Santín

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

Completed

Conditions

Intervention / Treatment

Detailed Description

The treatment of co-infected patients with normal ALT would be very important because the evolution of cirrhosis in this patients is quicker and frequently than mono-infected patients.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Huesca, Spain, 22004
        • Hospital San Jorge
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Tarragona, Spain, 43007
        • Hospital Joan XXIII
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
    • Alava
      • Vitoria, Alava, Spain, 01009
        • Hospital de Txagorritxu
    • Barcelona
      • Hospitalet, Barcelona, Spain, 08907
        • Consorci Sanitari Integral
      • Hospitalet, Barcelona, Spain, 08907
        • Hospital Universitari of Bellvitge
      • Mataró, Barcelona, Spain, 08304
        • Hospital General de Mataró
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa
    • Guipúzcoa
      • San Sebastián, Guipúzcoa, Spain, 20014
        • Hospital de Donostia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • Hospital Xeral-Cíes
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Peginterferon alfa-2a + ribavirin in normal ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other Names:
  • Pegasys + ribavirin
Active Comparator: 2
peginterferon alfa-2a + ribavirin in elevated ALT
Drug: Peginterferon alfa-2a + ribavirin in elevated ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other Names:
  • Pegasys + ribavirin

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

This is where you will find people and organizations involved with this study.

Sponsor

Miguel Santín

Investigators

  • Study Chair: Miguel Santin, Dr, Hospital Universitari of Bellvitge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 13, 2012

Study Record Updates

Last Update Posted (Estimate)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 12, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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