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

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ClinicalTrials.gov Identifier: NCT01684787
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : September 13, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Peginterferon alfa-2a + ribavirin in normal ALT Drug: Peginterferon alfa-2a + ribavirin in elevated ALT Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2006
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Pegasys + ribavirin

Outcome Measures

Primary Outcome Measures :
  1. % patients with RNA-HCV negative [ Time Frame: 24 weeks after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684787

Hospital de Txagorritxu
Vitoria, Alava, Spain, 01009
Consorci Sanitari Integral
Hospitalet, Barcelona, Spain, 08907
Hospital Universitari of Bellvitge
Hospitalet, Barcelona, Spain, 08907
Hospital General de Mataró
Mataró, Barcelona, Spain, 08304
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Hospital de Donostia
San Sebastián, Guipúzcoa, Spain, 20014
Hospital Xeral-Cíes
Vigo, Pontevedra, Spain, 36204
Hospital de Cruces
Baracaldo, Vizcaya, Spain, 48903
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinic
Barcelona, Spain, 08036
Hospital San Jorge
Huesca, Spain, 22004
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Joan XXIII
Tarragona, Spain, 43007
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Miguel Santin
Study Chair: Miguel Santin, Dr Hospital Universitari of Bellvitge
More Information

Responsible Party: Miguel Santin, Dr, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01684787     History of Changes
Other Study ID Numbers: Miguel Santín
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: September 2012

Keywords provided by Miguel Santin, Hospital Universitari de Bellvitge:
chronic hepatitis C
normal ALT
HIV/HCV patients

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs