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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miguel Santin, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01684787
First received: June 11, 2010
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Drug: Peginterferon alfa-2a + ribavirin in normal ALT
Drug: Peginterferon alfa-2a + ribavirin in elevated ALT
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • % patients with RNA-HCV negative [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2006
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684787

Locations
Spain
Hospital de Txagorritxu
Vitoria, Alava, Spain, 01009
Hospital Universitari of Bellvitge
Hospitalet, Barcelona, Spain, 08907
Consorci Sanitari Integral
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 Clinic
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital San Jorge
Huesca, Spain, 22004
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Joan XXIII
Tarragona, Spain, 43007
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Miguel Santin
Investigators
Study Chair: Miguel Santin, Dr Hospital Universitari of Bellvitge
  More Information

No publications provided

Responsible Party: Miguel Santin, Dr, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01684787     History of Changes
Other Study ID Numbers: Miguel Santín
Study First Received: June 11, 2010
Last Updated: September 12, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 31, 2014