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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

June 11, 2010
September 12, 2012
September 2006
May 2011   (final data collection date for primary outcome measure)
% patients with RNA-HCV negative [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01684787 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Peginterferon alfa-2a + ribavirin in normal ALT
    peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
    Other Name: Pegasys + ribavirin
  • Drug: Peginterferon alfa-2a + ribavirin in elevated ALT
    peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
    Other Name: Pegasys + ribavirin
  • Experimental: 1
    Peginterferon alfa-2a + ribavirin in normal ALT
    Intervention: Drug: Peginterferon alfa-2a + ribavirin in normal ALT
  • Active Comparator: 2
    peginterferon alfa-2a + ribavirin in elevated ALT
    Intervention: Drug: Peginterferon alfa-2a + ribavirin in elevated ALT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01684787
Miguel Santín
Yes
Miguel Santin, Hospital Universitari de Bellvitge
Miguel Santin
Not Provided
Study Chair: Miguel Santin, Dr Hospital Universitari of Bellvitge
Hospital Universitari de Bellvitge
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP